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Acetaminophen Tablet

Pronunciation

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:
Headache
Muscular aches
Backache
Minor pain of arthritis
The common cold
Toothache
Premenstrual and menstrual cramps
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
taken with other drugs containing acetaminophen
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 LABEL Item Code (Source) NDC:24236-641(NDC:16103-0353)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Product Characteristics
Color white Score no score
Shape ROUND (TABLET) Size 5mm
Flavor Imprint Code PH020
Contains         
Packaging
# Item Code Package Description
1 NDC:24236-641-02 30 TABLET (TABLET) in 1 BLISTER PACK
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: 03/2011
 
REMEDYREPACK INC.



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