LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [REMEDYREPACK INC.]

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LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [REMEDYREPACK INC.]
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NDC 70518-1507-0
Set ID 68606931-c0d9-4aa0-b4ec-88bab28b12b8
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active Ingredient (in each tablet)

    Aspirin 81mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • for the temporary relief of minor aches and pains or as recommended by your doctor
    • ask your doctor about other uses for this product
  • 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 a doctor

    Ask a doctor before use if

    • the 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 have asthma
    • you are taking a diuretic

    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

    • 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
    • allergic reaction occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs

    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 the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • 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 a doctor
    • children under 12 years: consult a doctor
  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • store at room temperature (15°-30°C)
    • avoid excess heat and moisture
  • Inactive ingredients

    Corn starch, dextrose monohydrate, FD&C yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

  • Questions?

    Adverse drug event call: (866) 562-2756  M-F 8AM - 4PM

  • PRINCIPAL DISPLAY PANEL

    DRUG: Low Dose Aspirin

    GENERIC: Aspirin

    DOSAGE: TABLET, CHEWABLE

    ADMINSTRATION: ORAL

    NDC: 70518-1507-0

    COLOR: orange

    FLAVOR: ORANGE

    SHAPE: ROUND

    SCORE: No score

    SIZE: 8 mm

    IMPRINT: PH034

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • ASPIRIN 81mg in 1

    INACTIVE INGREDIENT(S):

    • STARCH, CORN
    • DEXTROSE MONOHYDRATE
    • FD&C YELLOW NO. 6
    • SILICON DIOXIDE
    • SACCHARIN SODIUM
    • STEARIC ACID

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1507(NDC:16103-366)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-1507-030 in 1 BLISTER PACK; Type 0: Not a Combination Product10/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/08/2018
    Labeler - REMEDYREPACK INC. (829572556)
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