Acetaminophen (Systemic)

AHFS DI® Essentials™ Page 1 of 30
Acetaminophen (Systemic)
Introductory Information
Synthetic nonopiate derivative of p-aminophenol; produces analgesia and antipyresis.198, 207, 222
Class: 28:08.92 Analgesics and Antipyretics, Miscellaneous; cn103 (VA primary);
Brands*: Acephen®, Anacin® Aspirin Free Extra Strength, Axocet® (combination), Bupap®
(combination), Capital® and Codeine (combination), Ceta-Plus® (combination), Co-Gesic®
(combination), Endocet® (combination), Epidrin® (combination), Esgic-Plus® (combination),
Excedrin® Extra Strength (combination), Excedrin® Migraine (combination), Excedrin PM®
(combination), FeverAll®, Fioricet® (combination), Fioricet® with Codeine (combination), Gelpirin®
(combination), Genapap®, Genebs®, Goody's® (combination), Hydrogesic® (combination), Lorcet®
(combination), Lortab® (combination), Maxidone® (combination), Midol® Menstrual Complete
Maximum Strength (combination), Midol® Teen Menstrual Formula (combination), Midrin®
(combination), Ornex® (combination), Pamprin® Cramp (combination), Pamprin® Multi-Symptom
(combination), Percocet® (combination), Percogesic® (combination), Phrenilin® (combination),
Premsyn PMS® (combination), Roxicet® (combination), Sedapap® (combination), Tylenol®,
Tylenol® Extra Strength (combination), Tylenol® with Codeine (combination), Tylenol® PM Extra
Strength (combination), Tylox® (combination), Ultracet® (combination), Vanquish® (combination),
Vicodin® (combination), Zydone® (combination)
*also available generically
Generic Name: Acetaminophen

CAS Number: 103-90-2
Synonym: Paracetamol, APAP
Generic Name: Acetaminophen, Aspirin, and Caffeine

Synonym: Aspirin, Acetaminophen, and Caffeine
Generic Name: Acetaminophen and Codeine Phosphate

Synonym: Codeine Phosphate and Acetaminophen
Generic Name: Acetaminophen and Diphenhydramine Citrate

Synonym: Diphenhydramine Citrate and Acetaminophen
Generic Name: Oxycodone and Acetaminophen

Synonym: Acetaminophen and Oxycodone
Special Alerts:
[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug
manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly
combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit,
making these products safer for patients. This action will help to reduce the risk of severe liver injury
mk:@MSITStore:D:\KULIAH\SEM%206\Pr.%20Farkin\Dafpus\AHFS%202011.chm::/lj... 4/11/2023
and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for
severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face,
mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription
drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is
widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain
and fever. Examples of prescription products that contain acetaminophen include hydrocodone with
acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC
products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about
the potential for liver injury is already required on the label for OTC products containing
acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver
injury from OTC products. No drug shortages are expected, because the 3-year implementation period
should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the
acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking
acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to
patients who take these combination pain medications, and patients should continue to take them as
directed by their health care provider. The Drug Safety Communication provides additional
information for healthcare professionals, information for patients, a data summary and a list of all
affected products. For more information visit the FDA website at: [Web] and [Web].
Uses
Pain
Symptomatic relief of mild to moderate pain.198, 207, 222
Self-medication in children ≥6 years of age and adults for the temporary relief of minor aches and pain
associated with headache, muscular aches, backache, minor arthritis pain, common cold, toothache, and
menstrual cramps.222 Self-medication in infants and children for the temporary relief of minor aches and
pain associated with the common cold, flu, headache, sore throat, immunizations, toothache, muscle
aches, sprains, and overexertion.207, 235
Self-medication in fixed combination with aspirin and caffeine for the temporary relief of mild to
moderate pain associated with migraine headache.212, 213, 214 This combination also can be used for the
treatment of severe migraine headache if previous attacks have responded to similar nonopiate
analgesics or NSAIAs.231
Symptomatic treatment of pain associated with osteoarthritis; considered an initial drug of choice for
pain management in osteoarthritis patients.197, 199, 200, 201
Used in fixed combination with isometheptene and dichloralphenazone for symptomatic relief of tension
and vascular headaches.251, 252
Used in fixed combination with other agents (e.g., chlorpheniramine, dextromethorphan,
diphenhydramine, doxylamine, guaifenesin, phenylephrine, pseudoephedrine) for short-term relief of

minor aches and pain, headache, fever, and/or other symptoms (e.g., rhinorrhea, sneezing, lacrimation,
itching eyes, oronasopharyngeal itching, nasal congestion, cough) associated with seasonal allergic
rhinitis (e.g., hay fever), other upper respiratory allergies, or the common cold.253, 254, 255, 256, 257, 258,
259
Fever
Self-medication to reduce fever in infants, children, and adults.207, 222, 235
Dosage and Administration
Administration
Usually administered orally; may be administered rectally as suppositories in patients who cannot
tolerate oral therapy.207, 222, 226, 227, 228
Oral Administration
Swallow extended-release tablets whole; do not crush, chew, or dissolve in liquid.222
Place orally disintegrating, fixed-combination acetaminophen/caffeine tablets on the tongue to dissolve;

swallow with saliva.232 For best taste, do not chew.232
Because combinations and dosage strengths vary for fixed-combination preparations, consult
manufacturer's product labeling for appropriate dosage of the specific preparation.
Pediatric Administration
Acetaminophen oral drops generally used in infants 0-23 months of age.207 Use the calibrated dosing
device provided by the manufacturer for measurement of the dose.207
Oral suspension may be used in children ≥4 months age.207 Use the calibrated dosage cup provided by
the manufacturer for measurement of the dose.207
80-mg chewable tablets or orally disintegrating tablets may be used in children ≥2 years of age.207, 235
160-mg chewable tablets or orally disintegrating tablets or 325-mg conventional tablets commonly used
in children ≥6 years of age.207, 222, 235
Orally disintegrating tablets (Tylenol® Meltaways) should be allowed to dissolve in the mouth or should
be chewed before swallowing.237 Use caution to ensure that the correct number of tablets required for
the intended dose is removed from the blister package.236, 237
Rectal Administration
Dividing suppositories in an attempt to administer lower dosages may not provide a predictable dose.226
Some experts state that rectal acetaminophen preparations should not be used for self-medication in
children unless such use is specifically discussed with a clinician and parents or caregivers are instructed
to adhere to dosage and administration recommendations.226, 227, 228
Dosage
Pending revision, the material in this section should be considered in light of more recently available
information in the MEDWATCH notification at the beginning of this monograph.
Pediatric Patients
Dosage in children should be guided by body weight.207, 237 (See Pediatric Use under Cautions.)
Pain
Oral:
>Table 1. Dosage for Self-medication of Pain in Children up to 11 Years of Age207, 237

Age Weight Oral Dosea
≤3 months 2.7-5 kg 40 mg
4-11 months 5-8 kg 80 mg
12-23 months 8-11 kg 120 mg
2-3 years 11-16 kg 160 mg
4-5 years 16-21.5 kg 240 mg
6-8 years 21.5-27 kg 320 mg
9-10 years 27-32.5 kg 400 mg
11 years 32.5-43 kg 480 mg
aDose may be given every 4-6 hours as necessary (up to 5 times in 24 hours).198, 207, 237
For self-medication in children ≥12 years of age, 650 mg or 1 g every 4-6 hours as necessary (maximum
4 g daily).222
>Rectal
>Table 2. Dosage for Self-medication of Pain in Children 2-12 Years of Age198

Age Rectal Doseb
2-4 years 160 mg
4-6 years 240 mg
6-9 years 320 mg
9-11 years 320-400 mg
11-12 years 320-480 mg
bDose may be given every 4-6 hours as necessary (up to 5 times in 24 hours).198
Individualize dosage in children <2 years of age.226, 227, 228

For self-medication in children ≥12 years of age, 325-650 mg every 4 hours as necessary.198
Fever
Oral:
>Table 3. Dosage for Self-medication of Fever in Children up to 11 Years of Age207, 237

Age Weight Oral Dosec
≤3 months 2.7-5 kg 40 mg
4-11 months 5-8 kg 80 mg
12-23 months 8-11 kg 120 mg
2-3 years 11-16 kg 160 mg
4-5 years 16-21.5 kg 240 mg
6-8 years 21.5-27 kg 320 mg
9-10 years 27-32.5 kg 400 mg
11 years 32.5-43 kg 480 mg
cDose may be given every 4-6 hours as necessary (up to 5 times in 24 hours).198, 207, 237
For self-medication in children ≥12 years of age, 650 mg or 1 g every 4-6 hours as necessary (maximum
4 g daily).222
>Rectal
>Table 4. Dosage for Self-medication of Fever in Children 2-12 Years of Age198

Age Rectal Dosed
2-4 years 160 mg
4-6 years 240 mg
6-9 years 320 mg
9-11 years 320-400 mg
11-12 years 320-480 mg
dDose may be given every 4 hours as necessary (up to 5 times in 24 hours).198
Individualize dosage in children <2 years of age.226, 227, 228

For self-medication in children ≥12 years of age, 325-650 mg every 4 hours as necessary.198
Adults
Pain
Oral: For self-medication, 650 mg or 1 g every 4-6 hours as necessary (maximum 4 g daily).222
Alternatively, 1.3 g as extended-release tablets every 8 hours.222
>Rectal
325-650 mg every 4 hours as necessary.198
>Pain Associated with Migraine Headache

Oral: Acetaminophen, aspirin, and caffeine for self-medication: 2 tablets (each containing
acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) as a single dose.212
Acetaminophen, dichloralphenazone, and isometheptene mucate: 2 capsules (each containing
acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) initially,
followed by 1 capsule every hour until headache relieved (maximum 5 capsules in 12 hours).251, 252
>Pain Associated with Tension Headache

Oral: Acetaminophen, dichloralphenazone, and isometheptene mucate: 1 or 2 capsules (each containing
acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) every 4 hours
(up to 8 capsules daily).251, 252
>Pain Associated with Osteoarthritis

Oral: 1 g 4 times daily.149, a Alternatively, 1.3 g as extended-release tablets every 8 hours.199, 200, 201
Fever
Oral: For self-medication, 650 mg or 1 g every 4-6 hours as necessary (maximum 4 g daily).222
>Rectal
325-650 mg every 4 hours as necessary.198
Prescribing Limits
Pediatric Patients
Pain
Oral: Do not exceed recommended daily dosage.204, 205, 206, 207, 237 Self-medication should not exceed
5 days.207
Fever
Oral: Do not exceed recommended daily dosage.204, 205, 206, 207, 237 Self-medication should not exceed
3 days.207
Adults
Current limit is 4 g daily.197, 198, 222 Some experts recommend a maximum dosage of 3 g daily when
used for long-term therapy (e.g., ≥2 weeks).243 FDA is evaluating whether data exist to support
establishing a lower (i.e., <4 g daily) maximum daily dosage for certain patients (e.g., those who
chronically ingest alcohol).245, 246
Pain
>Oral or Rectal
Maximum 4 g daily.198, 222 Self-medication should not exceed 10 days.222
>Pain Associated with Migraine Headache

Oral: Acetaminophen, aspirin, and caffeine: Maximum for self-medication is 2 tablets (each containing
acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) in 24 hours unless otherwise directed by a
clinician.212
Acetaminophen, dichloralphenazone, and isometheptene mucate: Maximum 5 capsules (each containing
acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) in 12 hours.251,
252
>Pain Associated with Tension Headache

Oral: Acetaminophen, dichloralphenazone, and isometheptene mucate: Maximum 8 capsules (each
containing acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) in 24
hours.251, 252
>Pain Associated with Osteoarthritis

Oral: Maximum 4 g daily.197
Fever
>Oral or Rectal
Maximum 4 g daily.198, 222 Self-medication should not exceed 3 days.222
Cautions
Contraindications
• Known hypersensitivity to acetaminophen or any ingredient in the formulation.207, 222
Warnings/Precautions
Warnings
Hepatic Effects
Ingestion of a single toxic dose or multiple excessive doses can result in hepatotoxicity.222, 223
Following suspected overdosage, evaluate necessity of antidote (acetylcysteine) therapy.222, 223, 225, 229
Increased serum ALT concentrations reported in healthy individuals receiving acetaminophen 4 g daily
for 14 days in 1 study.239
Sensitivity Reactions
Sensitivity reactions reported rarely.222 If such reactions occur, discontinue the drug.207, 222
Sulfite Sensitivity
Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and
life-threatening or less severe asthmatic episodes) in certain susceptible individuals.a
General Precautions
Do not use multiple acetaminophen-containing preparations concomitantly.207, 222, 235
Phenylketonuria
Children's Tylenol® and Junior Strength Tylenol® chewable tablets contain aspartame (NutraSweet®),
which is metabolized in the GI tract to phenylalanine.207
Use of Fixed Combinations

When used in fixed combination with other agents (e.g., aspirin, caffeine, chlorpheniramine,
dextromethorphan, dichloralphenazone, diphenhydramine, doxylamine, guaifenesin, isometheptene,
phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated
with the concomitant agent(s).212, 251, 252, 253, 254, 255, 256, 257, 258, 259
Specific Populations
Pregnancy
Category B.b
Lactation
Distributed into milk;198 however, AAP considers acetaminophen to be usually compatible with breast-
feeding.250
Pediatric Use
Severe hepatotoxicity and death reported in children who apparently received acetaminophen dosages
exceeding those recommended202, 203, 204, 205, 206 (10-15 mg/kg per dose with a maximum of 5 doses
per day) for children.202, 204 Contributing factors include improper interpretation of dosing information
or failure to read such information, use of adult-strength preparations, use of excessive dosing because
of the perception that desired therapeutic effects had not been achieved, and lack of knowledge about the
potential toxicity of acetaminophen in excessive dosage.203, 204, 205, 206
Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations
containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in
combination for relief of symptoms of upper respiratory tract infection.247, 248 Limited evidence of
efficacy for these cold and cough preparations in this age group; appropriate dosages not established.247
Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and
efficacy in older children currently under evaluation. Because children 2-3 years of age also are at
increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold
preparations recently agreed to voluntarily revise the product labeling to state that such preparations
should not be used in children <4 years of age. During the transition period, some preparations on
pharmacy shelves will have the new recommendation ("do not use in children <4 years of age"), while
others will have the previous recommendation ("do not use in children <2 years of age"). FDA
recommends that parents and caregivers adhere to dosage instructions and warnings on the product
labeling that accompanies the preparation and consult a clinician about any concerns.
Interactions
Specific Drugs
Drug Interaction Comments

Increased risk of acetaminophen- Avoid regular or excessive use of
induced hepatotoxicity 101, 102, 103, 104, acetaminophen; alternatively, avoid
Alcohol 105, 107, 108, 109, 110, 111, 112, 113, 115, chronic ingestion of alcohol128, 129, 147,
116, 117, 120, 122, 123, 124, 125, 126, 127, 222 (see Prescribing Limits: Adults,
128, 129, 130, 131, 132 under Dosage and Administration)
Anticonvulsants Increased conversion of acetaminophen
Limit acetaminophen self-
(barbiturates, to hepatotoxic metabolites; increased
medication;165 dosage adjustment not
carbamazepine, risk of hepatotoxicity152, 157, 160, 162,
phenytoin) 163, 164, 165 required162, 163, 164
Anticoagulants, oral Possible increased PT168, 176 Clinical importance questioned;a

monitor anticoagulant activity if large
doses of acetaminophen used168, 169

No inhibition of antiplatelet effect of
Aspirin
aspirin144
Possible increased risk of Limit acetaminophen self-
Isoniazid
hepatotoxicity166 medication166
Possible increased risk of severe
Phenothiazines
hypothermiaa
Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration, with peak plasma concentration attained within 10-60
minutes (immediate-release preparations) or 60-120 minutes (extended-release preparations).a
Poor or variable absorption following rectal administration; considerable variation in peak plasma
concentrations attained; time to reach peak plasma concentration is substantially longer than after oral
administration.226, 227, 228
Food
Food may delay absorption following administration as extended-release tablets.148
Distribution
Extent
Rapidly distributed to most body tissues.a Crosses placenta and is distributed into breast milk.198
Plasma Protein Binding

25%.a
Elimination
Metabolism
Metabolized principally by sulfate and glucuronide conjugation; 226 small amounts (5-10%) oxidized by
CYP-dependent pathways (mainly CYP2E1 and CYP3A4) to a toxic metabolite, N-acetyl-p-
benzoquinoneimine (NAPQI).226 NAPQI is detoxified by glutathione and eliminated; any remaining
toxic metabolite may bind to hepatocytes and cause cellular necrosis.121, 226
Elimination Route
Mainly excreted in urine as conjugates.a
Half-life
1.25-3 hours.a
Special Populations
Following toxic doses or in patients with liver damage, plasma half-life may be prolonged.a
In patients with moderate to severe renal impairment, acetaminophen conjugates may accumulate.a
Stability
Storage
Oral
Tablets
Room temperature.222 Protect orally disintegrating tablets (Tylenol® Meltaways) from high
humidity.235 Protect grape-flavored orally disintegrating tablets from light.235
Suspension/Solution
Room temperature.207
Actions
• Exhibits analgesic and antipyretic activity.207, 222

• Weak, reversible, isoform-nonspecific cyclooxygenase inhibitor at dosages of 1 g daily.144 Inhibitory
effect on cyclooxygenase-1 is limited; does not inhibit platelet function.144
Advice to Patients
• Risk of severe hepatic damage with use of excessive dosages, with concomitant use of multiple
acetaminophen-containing preparations, and in those consuming substantial amounts of alcohol (e.g.,
≥3 alcohol-containing drinks per day) concomitantly.245, 246
• When used for self-medication, importance of reading the product labeling.222 Importance of not
exceeding the recommended daily dosage204, 205, 206, 207, 235, 238, 245, 246 and of not using other
acetaminophen-containing products (e.g., some cold and cough products) concomitantly.204, 207, 235,
238, 245, 246
• When used for self-medication in pediatric patients, importance of basing the dose on the child's
weight;205, 207 importance of not exceeding the recommended daily dosage.204, 205, 206, 207, 235
• Importance of advising parents and caregivers about the appropriate dose, frequency, duration of
therapy, and specific strength and formulation for an individual pediatric patient.226 Advise of the
danger of substituting alternative dosage forms, particularly adult for pediatric formulations.226
• Importance of ensuring that the correct amount of medication required for the intended dose is
administered (e.g., importance of using only the calibrated measuring device provided with the
particular formulation for measuring the dose, importance of ensuring that the strength and number of
dosage units correspond to the intended dose).205, 207, 226, 236
• Importance of seeking quick medical attention if ingested dosage exceeds recommended dosage.207,
222, 235
• Importance of limiting alcohol intake.128, 129, 147, 222

• Advise patients that paracetamol and APAP are other names for acetaminophen.260, 261
• Importance of informing clinicians of existing or contemplated concomitant therapy, including
prescription and OTC drugs (e.g., cough/cold preparations) as well as any concomitant illnesses.
• Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.
Acetaminophen
Routes Dosage Forms Strengths Brand Names Manufacturer
Bulk Powder
Oral Capsules 500 mg* Acetaminophen Capsules
167 mg/5
Solution
mL Tylenol® Extra-Strength Adult McNeil
100
mg/mL* Genapap® Drops Infant's Teva
Tylenol® Concentrated Drops Infant's McNeil

160 mg/5
Suspension
mL Tylenol® Suspension Children's McNeil
Tablets 325 mg* Genapap® Teva

Genebs® Teva
Tylenol® (scored) McNeil
500 mg* Genapap® Extra-Strength Caplets® Teva
Genapap® Extra-Strength Tablets Teva
Genapap® Gel-Coat Caplets® Teva
Genebs® Extra-Strength Caplets® Teva
Genebs® Extra-Strength Tablets Teva
Tylenol® Extra-Strength Rapid McNeil
Release Gelcaps
Tablets, extended-release, Tylenol® Arthritis Pain Extended
650 mg McNeil
film-coated Relief Caplets®
Tablets, film-coated 500 mg* Anacin® Aspirin Free Extra Strength Insight
Tablets
Tylenol® Extra Strength Caplets McNeil
Tablets, orally disintegrating 80 mg Tylenol® Meltaways Children's McNeil
160 mg Tylenol® Meltaways Junior Strength McNeil
Rectal Suppositories 80 mg FeverAll® Infants' Alpharma
120 mg* Acephen® G&W
FeverAll® Children's Alpharma

125 mg
FeverAll® Junior Strength Alpharma
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Acetaminophen, Aspirin, and Caffeine

Dosage
Routes Strengths Brand Names Manufacturer
Forms
260 mg/packet Acetaminophen,
Oral
For
Aspirin 520 mg/packet, and Caffeine Goody's® Extra Strength GlaxoSmithKline
solution Powder (combination)
32.5 mg/packet
325 mg/packet Acetaminophen,
Aspirin 500 mg/packet, and Caffeine Goody's® Cool Orange GlaxoSmithKline
65 mg/packet Powder (combination)
125 mg Acetaminophen, Aspirin 240
Tablets
mg, Caffeine 32 mg, and buffers Gelpirin® (combination) Alra
250 mg Acetaminophen, Aspirin 250 Excedrin® Extra

Strength Tablets Novartis
mg, and Caffeine 65 mg
(combination)
Excedrin® Migraine Novartis
Caplets (combination)
Geltabs (combination)
Tablets (combination)
Tablets, 194 mg Acetaminophen, Aspirin 227 Vanquish® Caplets Bayer
film-coated mg, Caffeine 33 mg, and buffers (combination)
250 mg Acetaminophen, Aspirin 250 Excedrin® Extra

Strength Caplets Novartis
mg, and Caffeine 65 mg
(combination)
Acetaminophen and Codeine Phosphate

Dosage
Forms
Oral Suspension
120 mg/5 mL Acetaminophen and Capital® and Codeine Actavis
Codeine Phosphate 12 mg/5 mL (combination) (C-V)
300 mg Acetaminophen and Acetaminophen and Codeine
Tablets
Codeine Phosphate 15 mg* Phosphate Tablets (C-III)
300 mg Acetaminophen and Tylenol® with Codeine No. 3 Ortho-
Codeine Phosphate 30 mg* (combination) (C-III) McNeil
300 mg Acetaminophen and Tylenol® with Codeine No. 4 Ortho-

Codeine Phosphate 60 mg* (combination) (C-III) McNeil
name
Acetaminophen and Diphenhydramine Citrate

Dosage
Forms
Oral
Tablets, film- 500 mg Acetaminophen and Excedrin PM® Caplets Novartis
coated Diphenhydramine Citrate 38 mg (combination)
Excedrin PM® Geltabs Novartis
(combination)
Excedrin PM® Tablets Novartis
(combination)
Oxycodone and Acetaminophen

Dosage
Forms
5 mg Oxycodone Hydrochloride Ortho-
Oral Capsules
and Acetaminophen 500 mg* Tylox® (combination) (C-II) McNeil
5 mg/5 mL Oxycodone
Solution Hydrochloride and Roxicet® (combination) (C-II) Roxane
Acetaminophen 325 mg/5 mL
2.5 mg Oxycodone Hydrochloride
Tablets
and Acetaminophen 325 mg Percocet® (combination) (C-II) Endo
5 mg Oxycodone Hydrochloride Endocet® (combination) (C-II; Endo

and Acetaminophen 325 mg* scored)
Percocet® (combination) (C-II; Endo
scored)
Roxicet® (combination) (C-II; Roxane
scored)
5 mg Oxycodone Hydrochloride Roxicet® 5/500 Caplets
Roxane
and Acetaminophen 500 mg (combination) (C-II; scored)
and Acetaminophen 325 mg Endocet® (combination) (C-II) Endo
Percocet® (combination) (C-II) Endo

Oxycodone Hydrochloride and
Acetaminophen Tablets
(combination) (C-II)
10 mg Oxycodone Hydrochloride

10 mg Oxycodone Hydrochloride
Oxycodone Hydrochloride and
Acetaminophen Tablets
(combination) (C-II)
Percocet 10/650® (combination) Endo
(C-II)
name
Other Acetaminophen Combinations

Dosage
Forms
325 mg with Butalbital 50 mg and
Oral Capsules
Caffeine 40 mg*
325 mg with Butalbital 50 mg,
Caffeine 40 mg, and Codeine Fioricet® with Codeine Watson
Phosphate 30 mg (combination) (C-III)
325 mg with Dichloralphenazone
100 mg and Isometheptene Mucate Midrin® (combination) (C-IV) Caraco
65 mg*
Epidrin® (combination) (C-IV) Excellium
500 mg with Hydrocodone Bitartrate Ceta-Plus® (combination) (C-
Seatrace
5 mg* III)
Hydrogesic® (combination) Edwards
(C-III)
650 mg with Butalbital 50 mg* Axocet® (combination) Savage
Phrenilin® Forte (combination) Valeant
Solution
167 mg/5 mL with Hydrocodone Lortab® Elixir (combination) UCB Pharma
Bitartrate 2.5 mg/5 mL* (C-III)
Tablets 325 mg with Butalbital 50 mg Phrenilin® (combination) Valeant

(scored)
325 mg with Butalbital 50 mg and
Caffeine 40 mg* Fioricet® (combination) Watson
325 mg with Phenyltoloxamine
Citrate 30 mg Percogesic® (combination) Medtech
325 mg with Pseudoephedrine
Hydrochloride 30 mg Ornex® Caplets (combination) BF Ascher
325 mg with Tramadol Ortho-
Hydrochloride 37.5 mg Ultracet® (combination) McNeil
400 mg with Hydrocodone Bitartrate
5 mg Zydone® (combination) (C-III) Endo
7.5 mg Zydone® (combination) (C-III) Endo

10 mg Zydone® (combination) (C-III) Endo
500 mg with Butalbital 50 mg and Esgic-Plus® (combination)
Mikart
Caffeine 40 mg (scored)
500 mg with Diphenhydramine Percogesic® Extra Strength
MedTech
Hydrochloride 12.5 mg Caplets® (combination)
500 mg with Hydrocodone Bitartrate Lortab® 2.5/500 (combination)
UCB Pharma
2.5 mg* (C-III; scored)
500 mg with Hydrocodone Bitartrate Co-Gesic® (combination) (C-
Schwarz
5 mg* III; scored)
Lortab® 5/500 (combination) UCB Pharma
(C-III; scored)
Vicodin® (combination) (C-III; Abbott
scored)
500 mg with Hydrocodone Bitartrate Lortab® 7.5/500 (combination)
UCB Pharma
500 mg with Hydrocodone Bitartrate Lortab®10/500 (combination)
UCB Pharma
10 mg (C-III; scored)
500 mg with Pamabrom 25 mg and Pamprin® Multi-Symptom
Chattem
Pyrilamine Maleate 15 mg Caplets (combination)
Premsyn PMS® Caplets Chattem
(combination)
500 mg with Pseudoephedrine Ornex® Maximum Strength Ascher
Hydrochloride 30 mg Caplets (combination)
650 mg with Butalbital 50 mg Bupap® (combination) ECR
Sedapap® (combination) Merz
(scored)
650 mg with Hydrocodone Bitartrate Lorcet® Plus (combination)
Forest
650 mg with Hydrocodone Bitartrate Lorcet® 10/650 (combination)
Forest
10 mg* (C-III; scored)
660 mg with Hydrocodone Bitartrate Vicodin® HP (combination)
Abbott
10 mg (C-III; scored)
750 mg with Hydrocodone Bitartrate Vicodin® ES (combination)
Abbott
7.5 mg (C-III; scored)
750 mg with Hydrocodone Bitartrate Maxidone® (combination) (C-
Watson
10 mg* III; scored)
Tablets, 250 mg with Magnesium Salicylate Pamprin® Cramp Caplets
Chattem
film-coated 250 mg and Pamabrom 25 mg (combination)
500 mg with Caffeine 60 mg and Midol® Menstrual Complete
Pyrilamine Maleate 15 mg Maximum Strength Caplets

Bayer
(combination)
Midol® Menstrual Complete
Maximum Strength Gelcaps Bayer
(combination)
500 mg with Diphenhydramine Tylenol® PM Extra Strength McNeil
Hydrochloride 25 mg Caplets (combination)
Tylenol® PM Extra Strength
Rapid Release Gelcaps McNeil
(combination)
Tylenol® PM Extra Strength
McNeil
Geltabs® (combination)
Midol® Teen Menstrual
500 mg with Pamabrom 25 mg Formula Caplets® Bayer
(combination)
name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing
information was updated 10/2011. For the most current and up-to-date pricing information, please visit
www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-
order locations and health insurance copays.
Acetaminophen 500MG Tablets (RUGBY): 700/$38.99 or 2100/$111.97
Acetaminophen-Codeine 120-12MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 240/

$19.99 or 720/$35.97
Acetaminophen-Codeine #2 300-15MG Tablets (TEVA PHARMACEUTICALS USA): 30/$14.99 or

60/$19.97
Acetaminophen-Codeine #3 300-30MG Tablets (MALLINCKRODT PHARM): 30/$15.99 or 60/$20.98
Acetaminophen-Codeine #4 300-60MG Tablets (MALLINCKRODT PHARM): 30/$17.99 or 90/$33.97
Butalbital-APAP-Caffeine 50-325-40MG Capsules (QUALITEST): 100/$39.99 or 300/$109.97
Butalbital-APAP-Caffeine 50-325-40MG Tablets (WEST-WARD): 30/$14.99 or 90/$39.97
Butalbital-APAP-Caffeine 50-500-40MG Tablets (WEST-WARD): 30/$18.99 or 90/$46.99
Dolgic Plus 50-750-40MG Tablets (SHIONOGI PHARMA): 100/$316.78 or 300/$891.00
Endocet 10-325MG Tablets (ENDO PHARMACEUTICALS): 20/$34.99 or 30/$52.48
Esgic 50-325-40MG Tablets (FOREST): 30/$69.99 or 90/$205.97
Esgic-Plus 50-500-40MG Tablets (FOREST): 30/$61.72 or 90/$175.24
Fioricet 50-325-40MG Tablets (WATSON LABS): 30/$68.14 or 90/$177.42
Fioricet/Codeine 50-325-40-30MG Capsules (WATSON LABS): 30/$125.27 or 90/$373.65
Hydrocodone-Acetaminophen 10-325MG Tablets (MALLINCKRODT PHARM): 30/$16.99 or 90/

$44.97

$39.97

$29.97

$36.97

$89.97
Hydrocodone-Acetaminophen 2.5-500MG Tablets (QUALITEST): 30/$12.99 or 90/$27.27

$29.98

$16.98
Hydrocodone-Acetaminophen 7.5-325MG Tablets (MALLINCKRODT PHARM): 30/$18.99 or 90/

$51.97
Hydrocodone-Acetaminophen 7.5-500MG/15ML Solution (QUALITEST): 473/$60.98 or 1419/$182.95

$17.98

$35.97

$23.97
Lorcet 10/650 10-650MG Tablets (FOREST): 30/$57.99 or 90/$159.97
Lorcet Plus 7.5-650MG Tablets (FOREST): 30/$48.49 or 90/$131.14
Lortab 7.5-500MG/15ML Elixir (UCB PHARMA): 120/$47.99 or 360/$119.97
Lortab 10 10-500MG Tablets (UCB PHARMA): 30/$55.99 or 90/$150.97
Lortab 2.5 2.5-500MG Tablets (UCB PHARMA): 30/$30.99 or 90/$78.97
Lortab 7.5 7.5-500MG Tablets (UCB PHARMA): 30/$54.99 or 90/$145.96
Norco 10-325MG Tablets (WATSON LABS): 30/$65.99 or 90/$192.98
Norco 5-325MG Tablets (WATSON LABS): 30/$49.67 or 90/$125.24
Norco 7.5-325MG Tablets (WATSON LABS): 30/$53.99 or 90/$151.17
Oxycodone-Acetaminophen 10-325MG Tablets (MALLINCKRODT PHARM): 20/$40.66 or 30/$60.99
Oxycodone-Acetaminophen 10-650MG Tablets (WATSON LABS): 20/$33.33 or 30/$49.99
Oxycodone-Acetaminophen 5-325MG Tablets (MALLINCKRODT PHARM): 20/$11.99 or 30/$17.99
Oxycodone-Acetaminophen 5-500MG Capsules (MALLINCKRODT PHARM): 20/$15.99 or 30/$23.99
Oxycodone-Acetaminophen 7.5-325MG Tablets (MALLINCKRODT PHARM): 20/$31.99 or 30/

$47.99
Oxycodone-Acetaminophen 7.5-500MG Tablets (WATSON LABS): 20/$25.99 or 30/$38.99
Percocet 10-325MG Tablets (ENDO PHARMACEUTICALS): 20/$127.99 or 30/$191.99
Percocet 2.5-325MG Tablets (ENDO PHARMACEUTICALS): 30/$90.99 or 60/$180.98
Roxicet 5-325MG/5ML Solution (ROXANE): 500/$46.19 or 1500/$138.57
Roxicet 5-325MG Tablets (ROXANE): 20/$12.99 or 30/$14.99
Stagesic 5-500MG Capsules (MAGNA PHARMACEUTICALS): 30/$24.99 or 90/$51.97
Tramadol-Acetaminophen 37.5-325MG Tablets (MYLAN): 30/$27.99 or 90/$80.97
Tylenol 8 Hour 650MG Controlled-release Tablets (MCNEIL CONSUMER): 50/$17.99 or 100/$25.97
Tylenol Arthritis Pain 650MG Controlled-release Tablets (MCNEIL CONSUMER): 100/$22.99 or 200/
$34.97
Tylenol with Codeine #4 300-60MG Tablets (MCNEIL): 30/$45.99 or 90/$119.97
Tylox 5-500MG Capsules (MCNEIL): 20/$49.54 or 30/$74.31
Ultracet 37.5-325MG Tablets (JANSSEN): 30/$63.99 or 90/$157.97
Vicodin 5-500MG Tablets (ABBOTT): 30/$49.99 or 90/$119.98
Vicodin ES 7.5-750MG Tablets (ABBOTT): 30/$51.90 or 90/$138.37
Vicodin HP 10-660MG Tablets (ABBOTT): 30/$53.99 or 90/$145.98
Xodol 10-300MG Tablets (SHIONOGI PHARMA): 100/$239.39 or 300/$674.98
Zamicet 10-325MG/15ML Solution (HAWTHORN PHARMACEUTICALS): 473/$164.88 or 1419/

$468.25
Zebutal 50-500-40MG Capsules (SHIONOGI PHARMA): 30/$51.99 or 90/$139.97
Zydone 10-400MG Tablets (ENDO PHARMACEUTICALS): 30/$31.99 or 90/$83.97
Zydone 5-400MG Tablets (ENDO PHARMACEUTICALS): 30/$27.99 or 90/$65.97
Zydone 7.5-400MG Tablets (ENDO PHARMACEUTICALS): 30/$32.99 or 90/$72.58
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AHFS DI® Essentials™ Page 1 of 30

Class: 28:08.92 Analgesics and Antipyretics, Miscellaneous; cn103 (VA primary);

*also available generically

Generic Name: Acetaminophen

Generic Name: Acetaminophen, Aspirin, and Caffeine

Generic Name: Acetaminophen and Codeine Phosphate

Generic Name: Acetaminophen and Diphenhydramine Citrate

Generic Name: Oxycodone and Acetaminophen

Symptomatic relief of mild to moderate pain.198, 207, 222

Used in fixed combination with other agents (e.g., chlorpheniramine, dextromethorphan,

diphenhydramine, doxylamine, guaifenesin, phenylephrine, pseudoephedrine) for short-term relief of

Self-medication to reduce fever in infants, children, and adults.207, 222, 235

Dosage and Administration

Place orally disintegrating, fixed-combination acetaminophen/caffeine tablets on the tongue to dissolve;

to adhere to dosage and administration recommendations.226, 227, 228

>Table 1. Dosage for Self-medication of Pain in Children up to 11 Years of Age207, 237

>Table 2. Dosage for Self-medication of Pain in Children 2-12 Years of Age198

Individualize dosage in children <2 years of age.226, 227, 228

>Table 3. Dosage for Self-medication of Fever in Children up to 11 Years of Age207, 237

>Table 4. Dosage for Self-medication of Fever in Children 2-12 Years of Age198

Individualize dosage in children <2 years of age.226, 227, 228

>Pain Associated with Migraine Headache

>Pain Associated with Tension Headache

>Pain Associated with Osteoarthritis

>Pain Associated with Migraine Headache

>Pain Associated with Tension Headache

>Pain Associated with Osteoarthritis

• Known hypersensitivity to acetaminophen or any ingredient in the formulation.207, 222

Use of Fixed Combinations

Drug Interaction Comments

Anticoagulants, oral Possible increased PT168, 176 Clinical importance questioned;a

doses of acetaminophen used168, 169

Plasma Protein Binding

• Exhibits analgesic and antipyretic activity.207, 222

• Importance of limiting alcohol intake.128, 129, 147, 222

Tylenol® Concentrated Drops Infant's McNeil

Tablets 325 mg* Genapap® Teva

FeverAll® Children's Alpharma

Acetaminophen, Aspirin, and Caffeine

250 mg Acetaminophen, Aspirin 250 Excedrin® Extra

250 mg Acetaminophen, Aspirin 250 Excedrin® Extra

Acetaminophen and Codeine Phosphate

300 mg Acetaminophen and Tylenol® with Codeine No. 4 Ortho-

Acetaminophen and Diphenhydramine Citrate

Oxycodone and Acetaminophen

5 mg Oxycodone Hydrochloride Endocet® (combination) (C-II; Endo

Percocet® (combination) (C-II) Endo

Percocet® (combination) (C-II) Endo

Other Acetaminophen Combinations

Tablets 325 mg with Butalbital 50 mg Phrenilin® (combination) Valeant

400 mg with Hydrocodone Bitartrate

7.5 mg Zydone® (combination) (C-III) Endo

500 mg with Caffeine 60 mg and Midol® Menstrual Complete

Pyrilamine Maleate 15 mg Maximum Strength Caplets

Acetaminophen 500MG Tablets (RUGBY): 700/$38.99 or 2100/$111.97

Acetaminophen-Codeine 120-12MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 240/

Acetaminophen-Codeine #2 300-15MG Tablets (TEVA PHARMACEUTICALS USA): 30/$14.99 or

Acetaminophen-Codeine #3 300-30MG Tablets (MALLINCKRODT PHARM): 30/$15.99 or 60/$20.98

Acetaminophen-Codeine #4 300-60MG Tablets (MALLINCKRODT PHARM): 30/$17.99 or 90/$33.97