ACEPHEN

ACEPHEN — acetaminophen suppository
REMEDYREPACK INC.

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
(click image for full-size original)
MM2
(click image for full-size original)
ACEPHEN acetaminophen suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-152(NDC:0713-0164)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (ACETAMINOPHEN) Acetaminophen 325 mg
Inactive Ingredients
Ingredient Name Strength
Glyceryl Monostearate
Peg-100 Stearate
Hydrogenated Coconut Oil
Sorbitan Monooleate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61786-152-07 12 SUPPOSITORY in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072344 03/09/2015
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2015 REMEDYREPACK INC.

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