ACTIVE INGREDIENT (in each rectal suppository)

Acetaminophen 650 mg

PURPOSE

Pain reliever/fever reducer

USES

temporarily
• reduces fever
• relieves minor aches, pains, and headache

WARNINGS

For rectal use only
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if
• an adult or child 12 years and older takes more than 6 suppositories in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• an adult takes 3 or more alcoholic drinks every day while using this product

Do not use
• in children under 12 years
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if
• you have liver disease
• you are taking the blood thinning drug warfarin

Stop use and ask a doctor if
• fever lasts more than 3 days (72 hours), or recurs
• pain gets worse or lasts more than 10 days
• new symptoms occur
• redness or swelling is present in the painful area
These may be signs of a serious condition.

IF PREGNANT OR BREAST-FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectum
• adults and children 12 years and older
• 1 suppository every 4 to 6 hours while symptoms persist
• do not exceed 6 suppositories in any 24-hour period
• children under 12 years: do not use

OTHER INFORMATION

• store at room temperature 15˚-30˚C (59˚-86˚F)

INACTIVE INGREDIENT

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate

QUESTIONS

call 1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION
READ AND KEEP CARTON FOR NEW LIVER WARNING
NDC 0713-0165-01
G&W ACEPHENTM Acetaminophen Suppositories USP 650 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

ACEPHEN
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0713-0165
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (Acetaminophen)	Acetaminophen	650 mg

Inactive Ingredients
Ingredient Name	Strength
Glyceryl Monostearate
Hydrogenated Coconut Oil
Peg-100 Stearate
Sorbitan Monooleate

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0713-0165-12	12 SUPPOSITORY In 1 BOX	None
2	0713-0165-01	100 SUPPOSITORY In 1 BOX	None
3	0713-0165-50	50 SUPPOSITORY In 1 BOX	None
4	0713-0165-10	1000 SUPPOSITORY In 1 BOX	None
5	0713-0165-05	500 SUPPOSITORY In 1 BOX	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072237	03/27/1992

Labeler - G&W Laboratories, Inc. (001271188)

Registrant - G&W Laboratories, Inc. (001271188)

Establishment
Name	Address	ID/FEI	Operations
G&W Laboratories, Inc.		001271188	MANUFACTURE

Revised: 01/2012G&W Laboratories, Inc.