Acetaminophen

Class: Analgesics and Antipyretics, Miscellaneous
VA Class: CN103
CAS Number: 103-90-2
Brands: Acephen, Anacin Aspirin Free Extra Strength, Axocet, Bupap, Capital and Codeine, Ceta-Plus, Co-Gesic, Endocet, Epidrin, Esgic-Plus, Excedrin Extra Strength, Excedrin Migraine, Excedrin PM, FeverAll, Fioricet, Fioricet with Codeine, Gelpirin, Genapap, Genebs, Goody’s, Hydrogesic, Lorcet, Lortab, Maxidone, Midol Menstrual Complete Maximum Strength, Midol Teen Menstrual Formula, Midrin, Ornex, Pamprin Cramp, Pamprin Multi-Symptom, Percocet, Percogesic, Phrenilin, Premsyn PMS, Roxicet, Sedapap, Tylenol, Tylenol Extra Strength, Tylenol with Codeine, Tylenol PM Extra Strength, Tylox, Ultracet, Vanquish, Vicodin, Zydone

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 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: and .

Introduction

Synthetic nonopiate derivative of p-aminophenol; produces analgesia and antipyresis.^{198 207 222}

Uses for Acetaminophen

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}

Acetaminophen 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

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).^{198 207 237}

Table 1. Dosage for Self-medication of Pain in Children up to 11 Years of Age207237

Age	Weight	Oral Dose
≤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

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

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).¹⁹⁸

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

Age	Rectal Dose
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

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

Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).^{198 207 237}

Table 3. Dosage for Self-medication of Fever in Children up to 11 Years of Age207237

Age	Weight	Oral Dose
≤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

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

Dose may be given every 4 hours as necessary (up to 5 times in 24 hours).¹⁹⁸

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

Age	Rectal Dose
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

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 for Acetaminophen

Contraindications

• 
  

  Known hypersensitivity to acetaminophen or any ingredient in the formulation.^{207 222}

  
  

Warnings/Precautions

Warnings

Hepatic Effects

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.

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

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.

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 recommended^{202 203 204 205 206} (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 for Acetaminophen

Specific Drugs

Drug	Interaction	Comments
Alcohol	Increased risk of acetaminophen-induced hepatotoxicity101 102 103 104 105 107 108 109 110 111 112 113 115 116 117 120 122 123 124 125 126 127 128 129 130 131 132	Avoid regular or excessive use of acetaminophen; alternatively, avoid chronic ingestion of alcohol128 129 147 222 (see Prescribing Limits: Adults, under Dosage and Administration)
Anticonvulsants (barbiturates, carbamazepine, phenytoin)	Increased conversion of acetaminophen to hepatotoxic metabolites; increased risk of hepatotoxicity152 157 160 162 163 164 165	Limit acetaminophen self-medication;165 dosage adjustment not required162 163 164
Anticoagulants, oral	Possible increased PT168 176	Clinical importance questioned;a monitor anticoagulant activity if large doses of acetaminophen used168 169
Aspirin	No inhibition of antiplatelet effect of aspirin144
Isoniazid	Possible increased risk of hepatotoxicity166	Limit acetaminophen self-medication166
Phenothiazines	Possible increased risk of severe hypothermiaa

Acetaminophen 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

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.

• 
  

  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 dosage^{204 205 206 207 235 238 245 246} 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.

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Acetaminophen

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder
Oral	Capsules	500 mg*	Acetaminophen Capsules
	Solution	167 mg/5 mL	Tylenol Extra-Strength Adult	McNeil
		100 mg/mL*	Genapap Drops Infant’s	Teva
			Tylenol Concentrated Drops Infant’s	McNeil
	Suspension	160 mg/5 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 Release Gelcaps	McNeil
	Tablets, extended-release, film-coated	650 mg	Tylenol Arthritis Pain Extended Relief Caplets	McNeil
	Tablets, film-coated	500 mg*	Anacin Aspirin Free Extra Strength Tablets	Insight
			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
		325 mg*	Acephen	G&W
			FeverAll Junior Strength	Alpharma
		650 mg*	Acephen	G&W

Acetaminophen, Aspirin, and Caffeine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution	260 mg/packet Acetaminophen, Aspirin 520 mg/packet, and Caffeine 32.5 mg/packet	Goody’s Extra Strength Powder	GlaxoSmithKline
		325 mg/packet Acetaminophen, Aspirin 500 mg/packet, and Caffeine 65 mg/packet	Goody’s Cool Orange Powder	GlaxoSmithKline
	Tablets	125 mg Acetaminophen, Aspirin 240 mg, Caffeine 32 mg, and buffers	Gelpirin	Alra
		250 mg Acetaminophen, Aspirin 250 mg, and Caffeine 65 mg	Excedrin Extra Strength Tablets	Novartis
			Excedrin Migraine Caplets	Novartis
			Excedrin Migraine Geltabs	Novartis
			Excedrin Migraine Tablets	Novartis
	Tablets, film-coated	194 mg Acetaminophen, Aspirin 227 mg, Caffeine 33 mg, and buffers	Vanquish Caplets	Bayer
		250 mg Acetaminophen, Aspirin 250 mg, and Caffeine 65 mg	Excedrin Extra Strength Caplets	Novartis

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Acetaminophen and Codeine Phosphate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL	Capital and Codeine (C-V)	Actavis
	Tablets	300 mg Acetaminophen and Codeine Phosphate 15 mg*	Acetaminophen and Codeine Phosphate Tablets (C-III)
		300 mg Acetaminophen and Codeine Phosphate 30 mg*	Tylenol with Codeine No. 3 (C-III)	Ortho-McNeil
		300 mg Acetaminophen and Codeine Phosphate 60 mg*	Tylenol with Codeine No. 4 (C-III)	Ortho-McNeil

Acetaminophen and Diphenhydramine Citrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	500 mg Acetaminophen and Diphenhydramine Citrate 38 mg	Excedrin PM Caplets	Novartis
			Excedrin PM Geltabs	Novartis
			Excedrin PM Tablets	Novartis

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Oxycodone and Acetaminophen

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg*	Tylox (C-II)	Ortho-McNeil
	Solution	5 mg/5 mL Oxycodone Hydrochloride and Acetaminophen 325 mg/5 mL	Roxicet (C-II)	Roxane
	Tablets	2.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg	Percocet (C-II)	Endo
		5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg*	Endocet (C-II; scored)	Endo
			Percocet (C-II; scored)	Endo
			Roxicet (C-II; scored)	Roxane
		5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg	Roxicet 5/500 Caplets (C-II; scored)	Roxane
		7.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg	Endocet (C-II)	Endo
			Percocet (C-II)	Endo
		7.5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg	Endocet (C-II)	Endo
			Oxycodone Hydrochloride and Acetaminophen Tablets (C-II)
			Percocet (C-II)	Endo
		10 mg Oxycodone Hydrochloride and Acetaminophen 325 mg	Endocet (C-II)	Endo
			Percocet (C-II)	Endo
		10 mg Oxycodone Hydrochloride and Acetaminophen 650 mg	Endocet (C-II)	Endo
			Oxycodone Hydrochloride and Acetaminophen Tablets (C-II)
			Percocet 10/650 (C-II)	Endo

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Acetaminophen Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	325 mg with Butalbital 50 mg and Caffeine 40 mg*
		325 mg with Butalbital 50 mg, Caffeine 40 mg, and Codeine Phosphate 30 mg	Fioricet with Codeine (C-III)	Watson
		325 mg with Dichloralphenazone 100 mg and Isometheptene Mucate 65 mg*	Midrin (C-IV)	Caraco
			Epidrin (C-IV)	Excellium
		500 mg with Hydrocodone Bitartrate 5 mg*	Ceta-Plus (C-III)	Seatrace
			Hydrogesic (C-III)	Edwards
		650 mg with Butalbital 50 mg*	Axocet	Savage
			Phrenilin Forte	Valeant
	Solution	167 mg/5 mL with Hydrocodone Bitartrate 2.5 mg/5 mL*	Lortab Elixir (C-III)	UCB Pharma
	Tablets	325 mg with Butalbital 50 mg	Phrenilin (scored)	Valeant
		325 mg with Butalbital 50 mg and Caffeine 40 mg*	Fioricet	Watson
		325 mg with Phenyltoloxamine Citrate 30 mg	Percogesic	Medtech
		325 mg with Pseudoephedrine Hydrochloride 30 mg	Ornex Caplets	BF Ascher
		325 mg with Tramadol Hydrochloride 37.5 mg	Ultracet	Ortho-McNeil
		400 mg with Hydrocodone Bitartrate 5 mg	Zydone (C-III)	Endo
		400 mg with Hydrocodone Bitartrate 7.5 mg	Zydone (C-III)	Endo
		400 mg with Hydrocodone Bitartrate 10 mg	Zydone (C-III)	Endo
		500 mg with Butalbital 50 mg and Caffeine 40 mg	Esgic-Plus (scored)	Mikart
		500 mg with Diphenhydramine Hydrochloride 12.5 mg	Percogesic Extra Strength Caplets	MedTech
		500 mg with Hydrocodone Bitartrate 2.5 mg*	Lortab 2.5/500 (C-III; scored)	UCB Pharma
		500 mg with Hydrocodone Bitartrate 5 mg*	Co-Gesic (C-III; scored)	Schwarz
			Lortab 5/500 (C-III; scored)	UCB Pharma
			Vicodin (C-III; scored)	Abbott
		500 mg with Hydrocodone Bitartrate 7.5 mg