POWERFUL PAIN MEDICINE - acetaminophen tablet 
REESE PHARMACEUTICAL CO.

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.

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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.

image of carton

POWERFUL PAIN MEDICINE 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (tablet) Size19mm
FlavorImprint Code 78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-762-5050 in 1 BOTTLE, PLASTIC
2NDC:10956-762-011 in 1 CARTON
2NDC:10956-762-2525 in 1 BOTTLE, PLASTIC
2NDC:10956-762-011 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/FEIBusiness Operations
REESE PHARMACEUTICAL CO.004172052repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
CONTRACT PHARMACAL057795122manufacture

Revised: 10/2010
Document Id: 08c563b1-8efe-428b-bc73-ecc7318ee492
Set id: 1b22a74e-8055-4388-ad74-d9b82213c9d6
Version: 1
Effective Time: 20101020
 
REESE PHARMACEUTICAL CO.