Powerful Pain Medicine

Dosage form: tablet
Ingredients: Acetaminophen 650mg
Labeler: REESE PHARMACEUTICAL CO.
NDC Code: 10956-762

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Acetaminophen;     650 mg

Acetaminophen 650 mg ;  pain reliever ; fever reducer

keep out of reach of children.

temporarily relieves minor aches and pains due to

common cold ; headaches ; toothaches ; muscular aches ;

backache ; minor arthritis pain ; menstrual cramps ; temporarily reduces fevers

LIVER  WARNING This product contains  acetaminophen.

severe liver damage may occur if adult takes more than 6 doses in 24 hours

which is the maximum daily amount.

child takes more than 5 doses in 24 hours

which is the maximum daily amount.

taken with other drugs containing acetaminophen.

adult has 3 or more alcoholic drinks everyday while using this product.

Directions

do not use more than directed

adults and children 12 years of age and older take 1 caplet

every 4 hours as needed.

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

children under 12 years of age;

do not use this adult product in children under 12 years of age

this will provide more than the recommended dose ( overdose ) of

non aspirin and could cause health problems.

polyvinylpyrrolidone ; pregelaatinized starch ; sodium starch glycolate ;

stearic acid.

POWERFUL PAIN MEDICINE 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-762
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (tablet) Size19mm
FlavorImprint Code78
Contains    
Packaging
#Item CodePackage Description
1NDC:10956-762-5050 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:10956-762-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2NDC:10956-762-2525 CARTON (TABLET) in 1 BOTTLE, PLASTIC
2NDC:10956-762-011 TABLET (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/30/1990
Labeler - REESE PHARMACEUTICAL CO. (004172052)
Registrant - REESE PHARMACEUTICAL CO. (004172052)
Establishment
NameAddressID/FEIOperations
REESE PHARMACEUTICAL CO.004172052repack, relabel
Establishment
NameAddressID/FEIOperations
CONTRACT PHARMACAL057795122manufacture

Revised: 10/2010
 
REESE PHARMACEUTICAL CO.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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