ACEPHEN - acetaminophen suppository 
G&W Laboratories, Inc.

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ACTIVE INGREDIENT (in each suppository)

Acetaminophen 325 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 12 suppositories in 24 hours, which is the maximum daily amount
• a child 6 to 12 years 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 6 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
• new symptoms occur
• pain gets worse or lasts more than 10 days
• 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

children under 6 yearsdo not use
children 6-12 years1 suppository every 4 to 6 hours
adults and children 12 years and older 2 suppositories every 4 to 6 hours

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 0713-0164-50
G&W ACEPHENTM Acetaminophen Suppositories USP 325 mg
Pain Reliever • Fever Reducer
50 Rectal Suppositories

Packaging Carton
ACEPHEN  
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0164
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
Glyceryl Monostearate 
Hydrogenated Coconut Oil 
Peg-100 Stearate 
Sorbitan Monooleate 
Packaging
#Item CodePackage Description
1NDC:0713-0164-1212 in 1 BOX
2NDC:0713-0164-01100 in 1 BOX
3NDC:0713-0164-5050 in 1 BOX
4NDC:0713-0164-666 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07234403/27/1992
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: 10217c91-e056-a2e3-c1b5-4cad77d9c44d
Set id: 20fae2ab-fcce-b026-be00-d9aa2f396f7d
Version: 1
Effective Time: 20120112
 
G&W Laboratories, Inc.