Label: CHEWABLE ASPIRIN- aspirin tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 5, 2019

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

  • Active Ingredient

    Aspirin 81 mg (NSAID*)
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Analgesic/antipyretic

  • Uses

    temporary relief of minor aches, pains and headaches

    to reduce fever associated with colds, sore throats, teething

  • 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.

    Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.

  • Do not use

    if you are allergic to aspirin or any other pain relievers/fever reducers

    for more than 10 days for pain unless directed by a doctor

    for more than 3 days for fever unless directed by a doctor

    for at least 7 days after a tonsillectomy or oral surgery

  • Ask a doctor before use if you have:

    asthma

    stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

    a child experiencing arthritis pain

    if you are;

    allergic to aspirin

    taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis

  • Stop use and ask a doctor if:

    an allergic reaction occurs, Seek medical help right away

    pain or fever persists

    new or unexpected symptoms occur

    redness or swelling is present

    ringing in ears or loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    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 definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.

  • Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    Do not use more than directed

    Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

    Children Under 12 years: Consult a doctor.

  • STORAGE AND HANDLING

    Store at room temperature

    tamper evident sealed packets

    do not use any opened or torn packets

  • Inactive Ingredients

    flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose

  • DESCRIPTION

    MADE IN USA

    Distributed by GENUINE FIRST AID

    600 Cleveland Str Suite 400, Clearwater, FL 33755

  • PRINCIPAL DISPLAY PANEL

                                                                                                2 Tablets

    GENUINE FIRST AID.

    Chewable Aspirin 81mg

  • PRINCIPAL DISPLAY PANEL

    Chewable Aspirin 81mg

  • INGREDIENTS AND APPEARANCE
    CHEWABLE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM CATION (UNII: LYR4M0NH37)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colororange (ORANGE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0012-12 in 1 PACKAGE; Type 0: Not a Combination Product04/02/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/02/2010
    Labeler - Genuine First Aid LLC (619609857)