Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 2, 2016

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  • 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®

    Acino Acetaminophen 112

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  FOR CHILDREN
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-112
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FAT, HARD (UNII: 8334LX7S21)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68784-112-1010 in 1 BOX; Type 0: Not a Combination Product12/29/2015
    2NDC:68784-112-5050 in 1 BOX; Type 0: Not a Combination Product12/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/29/2015
    Labeler - Acino Products, LLC (019385518)
    Registrant - Acino Products, LLC (019385518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acino Products, LLC019385518manufacture(68784-112)
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