Label: CHILDRENS ASPIRIN- aspirin tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 3, 2019

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

  • Drug Facts

    HOSPAK® UNIT DOSE PRODUCTS

    LOW STRENGTH ASPIRIN (NSAID)

    81 mg

    ORANGE FLAVORED, CHEWABLE TABLETS

    FOR INSTITUTIONAL USE ONLY

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Keep Out of Reach of Children

    Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    Temporary relief of minor aches and pains or as recommended by your doctor

    to reduce fever

  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock.

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ·are age 60 or older · have had stomach ulcers or bleeding problems ·take a blood thinning (anticoagulant) or steroid drug ·take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ·have 3 or more alcoholic drinks every day while using this product ·take more or for a longer time than directed.

    Do not use -if you are allergic to aspirin or any other pain reliever/fever reducer -this product for at least 7 days after tonsillectomy or oral surgery unless directed by doctor.

    Ask a doctor before use if -stomach bleeding warning applies to you -you have a history of stomach problems, such as heartburn -you have high blood pressure, heart disease, liver cirrhosis, or kidney disease -you are taking a diuretic -you have asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for ·gout ·diabetes ·arthritis

    Stop use and ask a doctor if ·an allergic reaction occurs. Seek medical help right away ·you experience any of the following signs of stomach bleeding ; feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better ·pain gets worse or lasts for more than 10 days ·redness or swelling is present ·new symptoms occur ·ringing in the ears or loss of hearing occurs ·You may report side effects to 1-888-952-0050.

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • Directions

    ·Drink a full glass of water with each dose ·adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by doctor ·children under 12 years: consult a doctor

  • Inactive ingredients

    dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

  • Storage

    Store at room temperature. Do not use if packet is torn, cut or opened.

    Questions? 1-847-458-5308

    Mfg. by: Allegiant Health, Deer Park, NY 11729

    Dist. By: Hospak® Unit Dose Products, Huntley, IL 60142

    Hospak is a trademark owned by its respective owner.

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L40737140818

    Rev. 08/17

  • Principal Display Panel

    Low Strength Aspirin (NSAID) 81 MG

    10 Flavored Chewable Tablets

    bag label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6752(NDC:66553-002)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (Peach) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code AZ;013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-6752-010 in 1 BAG06/02/2011
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/02/2011
    Labeler - Cardinal Health, Inc. (603638201)