Acephen TM 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)
• 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
ACEPHEN TM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

ACEPHEN
acetaminophen suppository

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0713-0164-01	100 in 1 BOX	03/27/1992	04/30/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0713-0164-50	50 in 1 BOX	03/27/1992	04/30/2022
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0713-0164-12	12 in 1 BOX	03/27/1992	04/30/2022
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072344	03/27/1992	04/30/2022

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

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

Revised: 4/2022

Document Id: dd1b1864-603d-2c53-e053-2a95a90ac7ec

Set id: 20fae2ab-fcce-b026-be00-d9aa2f396f7d

Version: 6

Effective Time: 20220420

Cosette Pharmaceuticals, Inc.

Acephen TM Acetaminophen Suppositories USP 325 mg