ACEPHEN- acetaminophen suppository

ACEPHEN by

Drug Labeling and Warnings

ACEPHEN by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

 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)
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

INGREDIENTS AND APPEARANCE

ACEPHEN  
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0164
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0164-01	100 in 1 BOX	03/27/1992
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0713-0164-50	50 in 1 BOX	03/27/1992
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0713-0164-12	12 in 1 BOX	03/27/1992
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072344	03/27/1992

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Business Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis(0713-0164) , manufacture(0713-0164) , label(0713-0164) , pack(0713-0164)