OTC Medication Information: Acetaminophen For Children

ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository
NuCare Pharmaceuticals,Inc.

Active ingredient (in each rectal suppository)

Acetaminophen 120 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

  • reduces fever
  • relieves minor aches, pains, and headache

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

Stop use and ask a doctor if

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

These may be signs of a serious condition.

Keep out of reach of children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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

  • 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

  • store at 20-25 ° C (68-77 ° F) or in a cool place
  • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Inactive ingredient

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

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ACETAMINOPHEN FOR CHILDREN
acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4172(NDC:45802-732)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4172-6 6 SUPPOSITORY in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070607 12/14/2010
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4172)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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