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ACEPHEN by Central Texas Community Health Centers

Medically reviewed on Mar 9, 2018

Dosage form: suppository
Ingredients: Acetaminophen 325mg
Labeler: Central Texas Community Health Centers
NDC Code: 76413-302

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 years                      do not use
children 6-12 years

                      1 suppository every 4 to 6 hours

                       (maximum of 5 doses in 24 hours)

adults and children

12 years and older

                       2 suppositories every 4 to 6 hours

                       (maximum of 6 doses)

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

PRINCIPAL DISPLAY PANEL - 325 mg Suppository Box Label

CommUnityCare Federally Qualified Health Centers

Acetaminophen
325mg Supp.

Date:

Name:
Dr.

Hancock item only

123456

1/1/01

Acetaminophen 325mg Suppositories NDC 76413-302-12

Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

ACEPHEN  
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-302(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:76413-302-1212 SUPPOSITORY in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07234403/27/1992
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-302), RELABEL(76413-302)

 
Central Texas Community Health Centers

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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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