ACEPHEN- acetaminophen suppository 
Cosette Pharmaceuticals, Inc.

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Acephen TM Acetaminophen Suppositories USP

650 mg

ACTIVE INGREDIENT (in each rectal suppository)

Acetaminophen 650 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
• 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 12 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
• pain gets worse or lasts more than 10 days
• new symptoms occur
• 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
• carefully insert suppository well up into rectum
• adults and children 12 years and older
      • 1 suppository every 4 to 6 hours while symptoms persist     
      • do not exceed 6 doses in any 24-hour period
• children under 12 years: do not use

OTHER INFORMATION

• store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate

QUESTIONS?

call 1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0165-01
G&W ACEPHEN TM Acetaminophen Suppositories USP 650 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

carton_100
ACEPHEN 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0165
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0165-1212 in 1 BOX; Type 0: Not a Combination Product03/27/199205/31/2022
2NDC:0713-0165-01100 in 1 BOX; Type 0: Not a Combination Product03/27/199212/31/2021
3NDC:0713-0165-5050 in 1 BOX; Type 0: Not a Combination Product03/27/199205/31/2022
4NDC:0713-0165-101000 in 1 BOX; Type 0: Not a Combination Product03/27/199204/30/2014
5NDC:0713-0165-05500 in 1 BOX; Type 0: Not a Combination Product03/27/199204/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07223703/27/199205/31/2022
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Cosette Pharmaceuticals, Inc. (116918230)
Establishment
NameAddressID/FEIBusiness Operations
Cosette Pharmaceuticals, Inc.116918230analysis(0713-0165) , manufacture(0713-0165) , label(0713-0165) , pack(0713-0165)

Revised: 4/2022
Document Id: dd1b0d7c-51ad-cd10-e053-2995a90af3a5
Set id: ab9a9048-75b7-904c-6683-06d7de69ec52
Version: 4
Effective Time: 20220420
 
Cosette Pharmaceuticals, Inc.