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Name:Acetaminophen
Manufacturer:Cardinal Health
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen 500 mg Tablets

ACETAMINOPHEN - acetaminophen tablet 
Cardinal Health

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.

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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

bag label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5837(NDC:0182-8453)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code 44;148
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5837-0 10 BLISTER PACK ( BLISTER PACK) in 1 BAG contains a BLISTER PACK
1 1 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-5837-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/02/2011

Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK

Revised: 06/2011 Cardinal Health



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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