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 120 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 your child inserts
more than 5 suppositories in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
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
if your child is 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 your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if
fever lasts more than 3 days (72 hours), or recurs
you need to use this product for pain for more than 5 days continuously
Severe or recurrent pain, or high or continued fever may indicate a serious illness.

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 children even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.
do not use more than directed
remove foil wrapper
insert suppository well up into rectum
children 3-6 years
   1 suppository every 4 to 6 hours while symptoms persist
    do not exceed 5 suppositories in any 24-hour period
children under 3 years: ask a doctor

Other Information

for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
store at 8˚-25˚C (46˚-77˚F)

Inactive ingredients

butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80

Questions?

call 1-800-922-1038
Monday-Friday 9am-4pm EST

PRINCIPAL DISPLAY PANEL

NDC: 0713-0118-50
G&W Pediatric ACEPHENTM Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever Fever Reducer
50 Rectal Suppositories



08/2013

INGREDIENTS AND APPEARANCE

ACEPHEN  
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0118
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	120 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0118-12	12 in 1 BOX; Type 0: Not a Combination Product	01/01/1982
2	NDC: 0713-0118-01	100 in 1 BOX; Type 0: Not a Combination Product	01/01/1982
3	NDC: 0713-0118-50	50 in 1 BOX; Type 0: Not a Combination Product	01/01/1982

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018060	01/01/1982

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Business Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis(0713-0118) , manufacture(0713-0118) , label(0713-0118) , pack(0713-0118)