Acetaminophen
FDA Label NDC 68784-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acino Products, Llc for the product Acetaminophen (NDC 68784-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredient (in each rectal suppository), purpose, keep out of reach of children., uses, warnings, do not use, ask a doctor before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient (In Each Rectal Suppository)

Acetaminophen 120 mg

Purpose

Pain reliever/fever reducer

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 for adults as well as for children even if you do not notice any signs or symptoms.

Uses

  • temporarily reduces fever
  • temporarily 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

  • 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 could be signs of a serious condition.

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

    3 to 6 years

     Do not use unless directed by a doctor

    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)
  • tamper evident suppositories are individually wraped.

    • Do not use if printed wrapper is open or damaged.

Inactive Ingredients

Glycerol Monostearate, Hydrogenated Vegetable Oil, Lecithin, Polysorbate 80

Questions Or Comments?

Call (609-695-4300)

Acetaminophen Suppositories For Children Product Label

Acion Products

NDC 68784-112-10

*Compare to the active ingredient in Fever All

For Children

Acetaminophen Suppositories USP, 120 mg

Pain reliever/Fever reducer

Age 3-6

See New Warning

10 Rectal Suppositories 120 mg each

Tamper-evident: Suppositories are individually wrapped. Do not use if printed wrapper is open or damaged

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION


Acino Products LLC

9B South Gold Drive

Hamilton, NJ 08691.

MADE IN THE USA

*This product is not manufactured or distributed by Acino Mid Atlantic LLC the distributed of Fever All®

* Please review the disclaimer below.