Acetaminophen Tablet

Dosage Form: tablet

OTC - ACTIVE INGREDIENT

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 325 mg


PURPOSES

Pain Reliever/Fever Reducer


USES

for the temporary relief of minor aches and pains due to:

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Headache

●

Muscular aches

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Backache

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Minor pain of arthritis

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The common cold

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Toothache

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Premenstrual and menstrual cramps

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Temporarily reduces fever.

Warnings

WARNINGS

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 than 5 doses in 24 hours

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taken with other drugs containing acetaminophen

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adult has 3 or more alcoholic drinks every day while using this product

●

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.

●

if you are allergic to acetaminophen or any of the inactive ingredients in this product

●

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

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.

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

Keep out of reach of children.

Overdosage

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 -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:

acetaminophen and may cause liver damage.



OTHER INFORMATION

●

Store at room temperature 15(59

●

Use by expiration date on package.

●

INACTIVE INGREDIENT

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions? To report a Serious Adverse Event contact 1-877-835-5472.

*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol

INACTIVE INGREDIENT

POVIDONE

STARCH, CORN

SODIUM STARCH GLYCOLATE TYPE A POTATO

STEARIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Acetaminophen

GENERIC: Acetaminophen

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 24236-641-02

STRENGTH:325 mg

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 5 mm

IMPRINT: 30

QTY: 30

ACETAMINOPHEN  acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24236-641 (16103-0353) 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 No Inactive Ingredients Found

Product Characteristics Color white Score no score Shape ROUND (TABLET) Size 5mm Flavor Imprint Code PH020 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24236-641-02 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075659	03/09/2011

Labeler - REMEDYREPACK INC. (829572556)

Revised: 03/2011REMEDYREPACK INC.

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