POWERFUL PAIN MEDICINE- acetaminophen tablet

Powerful Pain Medicine by

Drug Labeling and Warnings

Powerful Pain Medicine by is a Otc medication manufactured, distributed, or labeled by REESE PHARMACEUTICAL CO., CONTRACT PHARMACAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen;     650 mg

PURPOSE

Acetaminophen 650 mg ;  pain reliever ; fever reducer

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children.

INDICATIONS & USAGE

temporarily relieves minor aches and pains due to

common cold ; headaches ; toothaches ; muscular aches ;

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

polyvinylpyrrolidone ; pregelaatinized starch ; sodium starch glycolate ;

stearic acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POWERFUL PAIN MEDICINE 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10956-762
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (tablet)	Size	19mm
Flavor		Imprint Code	78
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10956-762-50	50 in 1 BOTTLE, PLASTIC
2	NDC: 10956-762-01	1 in 1 CARTON
2	NDC: 10956-762-25	25 in 1 BOTTLE, PLASTIC
2	NDC: 10956-762-01	1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/30/1990

Labeler - REESE PHARMACEUTICAL CO. (004172052)

Registrant - REESE PHARMACEUTICAL CO. (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
REESE PHARMACEUTICAL CO.		004172052	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
CONTRACT PHARMACAL		057795122	manufacture