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Acetaminophen

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 55154-5552

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Acetaminophen 500 mg Caplets

Drug Information

Acetaminophen

500 mg Caplets

Extra Strength

Pain Reliever/Fever Reducer

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Keep Out of Reach of Children

Keep out of reach of children.

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use with any other product containing acetaminophen

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

    These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning: Taking more than the recommended dose

(overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
  • Adults and children 12 years of age and over
  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
  • Children under 12 years
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredients

pregelatinized starch, povidone, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, carnauba wax

How Supplied

How Supplied

Acetaminophen Extra Strength Caplets are available as follows:

500 mg - White to off-white, capsule shaped, film coated caplets with 112 debossed on one side.

NDC 51079-396-20 - Unit dose blister packages of 100 (10 cards of 10 caplets each).

NDC 51079-396-19 - Robot Ready blister packages of 25 (25 cards of 1 caplet each).

Storage

Store between 20-25°C (68-77°F)

Other Information
  • do not use if blister units are torn, broken or show any signs of tampering

Questions? 1-800-848-0462

Serious side effects associated with use of this product may be reported to this number.

Manufactured by:

Amneal Pharmaceuticals Corp.

Paterson, NJ 07504

Packaged and Distributed by:

UDL Laboratories, Inc.

Rockford, IL 61103

S-8777 R3

1/09

Principal Display Panel

Acetaminophen Caplets

500 mg

Extra Strength

10 Caplets

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5552(NDC:51079-396)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
CARNAUBA WAX 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code112
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-5552-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 07/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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