Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 6, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • Acetaminophen For Children

    Label Image
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  FOR CHILDREN
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0001(NDC:45802-732)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED ACID (UNII: H3E878020N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0001-012 in 1 CARTON01/06/202501/06/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07060712/14/201009/30/2026
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!