Label: ACEPHEN- acetaminophen suppository
- NDC Code(s): 0713-0118-01, 0713-0118-12, 0713-0118-50
- Packager: Cosette Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated July 26, 2019
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- ACTIVE INGREDIENT (in each rectal suppository)
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
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.
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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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)