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Acetaminophen

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 55154-5837

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 Tablets

Drug Facts

Extra Strength

Active ingredient

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

Uses

Temporarily relieves minor aches and pains due to headache, backache, toothache, flu, minor pain of arthritis, muscular aches, pre-menstrual and menstrual cramps, the common cold and temporarily reduces fever.

Warnings

This package is intended for institutional use only.

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

Do not use with any other product containing acetaminophen.

Stop use and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days or fever gets worse or last more than 3 days. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken.

This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.

Directions

do not take more than directed (see overdose warning)

  • adults and children 12 years and over: take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by doctor.
  • children under 12 years: Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Overdose

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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive ingredients

povidone, starch, stearic acid

Storage

Store at Room Temperature 15-30 C (59-86 F)

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

Manufactured for

Goldline Laboratories, INC.

a subsidiary of IVAX Pharmaceuticals, Inc.

Miami, FL 33137-3227

by: LNK International, Inc.

Hauppauge, NY 11788

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Acetaminophen Tablets USP

500 mg

10 Tablets

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5837(NDC:0182-8453)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code44;148
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-5837-010 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: 06/2011
 
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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