Pediatric Acephen TM Acetaminophen Suppositories USP, 120 mg

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 ACEPHEN TM Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever • Fever Reducer
50 Rectal Suppositories

08/2013

ACEPHEN
acetaminophen suppository

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0713-0118-12	12 in 1 BOX; Type 0: Not a Combination Product	01/01/1982	12/31/2020
2	NDC:0713-0118-01	100 in 1 BOX; Type 0: Not a Combination Product	01/01/1982	08/31/2020
3	NDC:0713-0118-50	50 in 1 BOX; Type 0: Not a Combination Product	01/01/1982	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018060	01/01/1982	12/31/2020

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

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

Revised: 4/2022

Document Id: dd1b1864-6031-2c53-e053-2a95a90ac7ec

Set id: 32bbe845-7f0e-c33d-adb2-659f18fedfa9

Version: 8

Effective Time: 20220420

Cosette Pharmaceuticals, Inc.