ACEPHEN- acetaminophen suppository 
REMEDYREPACK INC.

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AcephenTM Acetaminophen Suppositories USP325 mg

OTC - ACTIVE INGREDIENT

Acetaminophen 325 mg

 

OTC - PURPOSE

Pain reliever/fever reducer

 

INDICATIONS & USAGE

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.

 

DOSAGE & ADMINISTRATION

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)

 

OTC - KEEP OUT OF REACH OF CHILDREN

• store at room temperature 15˚-30˚C (59˚-86˚F)

 

INACTIVE INGREDIENT

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

 

OTC - QUESTIONS

call 1-800-922-1038

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: ACEPHEN


GENERIC: Acetaminophen


DOSAGE: SUPPOSITORY


ADMINSTRATION: RECTAL


NDC: 61786-152-07


ACTIVE INGREDIENT(S):

  • Acetaminophen 325mg in 1


INACTIVE INGREDIENT(S):

  • Glyceryl Monostearate
  • Peg-100 Stearate
  • Hydrogenated Coconut Oil
  • Sorbitan Monooleate


PACKAGING: 12 in 1 BOX




MM1

MM2

ACEPHEN 
acetaminophen suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-152(NDC:0713-0164)
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-152-0712 in 1 BOX; Type 0: Not a Combination Product01/16/201501/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07234401/16/201501/16/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.