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ACEPHEN by G&W Laboratories, Inc.

Medically reviewed on Jan 12, 2018

Dosage form: suppository
Ingredients: Acetaminophen 650mg
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0165

AcephenTM Acetaminophen Suppositories USP
650 mg

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 doses 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.

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 for children even if you do not notice any signs or symptoms.

DIRECTIONS

do not use more than directed
• remove foil wrapper
• carefully 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 doses 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 INGREDIENTS

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

QUESTIONS?

call 1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 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 SUPPOSITORY (SUPPOSITORY) in 1 BOX
2NDC:0713-0165-01100 SUPPOSITORY (SUPPOSITORY) in 1 BOX
3NDC:0713-0165-5050 SUPPOSITORY (SUPPOSITORY) in 1 BOX
4NDC:0713-0165-101000 SUPPOSITORY (SUPPOSITORY) in 1 BOX
5NDC:0713-0165-05500 SUPPOSITORY (SUPPOSITORY) 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/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE(0713-0165)

 
G&W Laboratories, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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