Label: ACETAMINOPHEN suppository
Contains inactivated NDC Code(s)
NDC Code(s): 54868-5624-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0713-0118
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 6, 2012
If you are a consumer or patient please visit this version.
- 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
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
DOSAGE & ADMINISTRATION
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 INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5624(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-100 Stearate (UNII: YD01N1999R) Polysorbate 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5624-0 12 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018060 06/29/2006 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel