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


Acetaminophen, USP 325 mg

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, USP 325 mg

Active ingredient

Acetaminophen 325 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours
  • do not use more than 10 days unless directed by a doctor

Children 6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

Children under 6 years

  • do not use this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredients

pregelatinized starch, povidone, stearic acid

Storage

Store between 20-25 C (68-77 F)

Do not use if blister units are torn, 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.

How Supplied:

Acetaminophen Tablets are available as follows:

325 mg - White, round, flat faced, beveled tablets debossed "AN" above bisect and "211" below bisect on one side and plain on the other side.

NDC 51079-002-20 - Unit dose blister packages of 100 (10 cards of 10 talbets each).

NDC 51079-002-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).

NDC 51079-002-22 - Unit dose blister packages of 200 (10 cards of 20 tablets each).

Store between 20-25C (68-77F).

ANUFACTURED BY:

Amneal Pharmaceuticals Corp.

Paterson, NJ 07504

Packaged and Distributed by:

UDL Laboratories, Inc. Rockford, IL 61103

S-8927 R4

11/08

Principal Display Panel

Acetaminophen Tablets, USP

325 mg

10 x 2 Tablets

Bag Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5352(NDC:51079-002)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
POVIDONE  
STEARIC ACID  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code AN;211
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5352-0 10 BLISTER PACK ( BLISTER PACK) in 1 BAG contains a BLISTER PACK
1 2 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-5352-0)

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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