Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-4151-1 - Packager: NuCare Pharmaceutiacals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-732
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 15, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each rectal suppository)
- Purposes
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses 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.
For rectal use only
Do not use
- 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
- your child has liver disease
- your child is taking the blood thinning drug warfarin
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Directions
- this product does not contain directions or warnings for adult use
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
Dosing Chart
Age
Dose
under 3 years
Do not use unless directed by a doctor
3 to 6 years
Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
- Other information
- Inactive ingredient
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN FOR CHILDREN
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4151(NDC:45802-732) 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 COTTONSEED OIL (UNII: H3E878020N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4151-1 12 in 1 BOX; Type 0: Not a Combination Product 11/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070607 12/14/2010 Labeler - NuCare Pharmaceutiacals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-4151)