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Acetaminophen

Cardinal Health

Acetaminophen, USP 325 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

See new warning information.

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of the reach of children.

Acetaminophen Uses

To reduce fever and for the temporary relief of minor aches and pains due to headache, backache, the common cold, muscular aches, minor pain of arthritis, toothache, premenstrual and menstrual cramps. Temporarily reduces fever.

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use. This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more that 5 doses in 24 hours.
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

Ask a doctor before use if the user has liver disease.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults and children
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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.

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours.
children 6 to 11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours.
children under 6 years Do not use adult regular strength products in children under 6 years of age: this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Inactive ingredients

povidone starch, stearic acid

Storage

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

Protect from moisture, heat and light

Questions? Call 1-888-838-2872, weekdays,

8 AM - 5 PM Eastern Time

Manufactured for:

GOLDLINE LABORATORIES, INC.

Sellersville, PA 18960

by: LNK International, Inc.

Hauppauge, NY 11788

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Acetaminophen Tablets USP

325 mg

10 Tablets

Acetaminophen

Acetaminophen

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-5842(NDC:0182-8447)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
povidone
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm 44;104 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-5842-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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