ACEPHEN - acetaminophen suppository 
G&W Laboratories, Inc.

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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

Packaging Carton
ACEPHEN  
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0165
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
Glyceryl Monostearate 
Hydrogenated Coconut Oil 
Peg-100 Stearate 
Sorbitan Monooleate 
Packaging
#Item CodePackage Description
1NDC:0713-0165-1212 in 1 BOX
2NDC:0713-0165-01100 in 1 BOX
3NDC:0713-0165-5050 in 1 BOX
4NDC:0713-0165-101000 in 1 BOX
5NDC:0713-0165-05500 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07223703/27/1992
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIBusiness Operations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
Document Id: f26eaa9f-7306-29aa-d77c-5e38d6050ae0
Set id: ab9a9048-75b7-904c-6683-06d7de69ec52
Version: 1
Effective Time: 20120112
 
G&W Laboratories, Inc.