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ACEPHEN by G&W Laboratories, Inc.

Medically reviewed on April 14, 2017

Dosage form: suppository
Ingredients: Acetaminophen 325mg
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0164

AcephenTM  Acetaminophen Suppositories USP
325 mg

 Active Ingredient (in each rectal 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
 a child 6 to 12 years takes more than 5 doses in 24 hours
•  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 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 for children even if you do not notice any signs or symptoms.

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 (maximum of 5 doses in 24 hours)
adults and children 12 years and older2 suppositories every 4 to 6 hours (maximum of 6 doses)

Other Information

• store at room temperature 15˚-30˚C (59˚-86˚F)
• do not use if imprinted suppository wrapper is opened or damaged

INACTIVE INGREDIENTS

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

QUESTIONS?

call 1-800-922-1038

PRINCIPAL DISPLAY PANEL

NDC 0713-0164-01
ACEPHENTM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

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:0713-0164-01100 BLISTER PACK in 1 BOX
11 SUPPOSITORY in 1 BLISTER PACK
2NDC:0713-0164-5050 BLISTER PACK in 1 BOX
21 SUPPOSITORY in 1 BLISTER PACK
3NDC:0713-0164-1212 BLISTER PACK in 1 BOX
31 SUPPOSITORY in 1 BLISTER PACK
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/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE(0713-0164)

 
G&W Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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