SAFETY COATED ASPIRIN (ASPIRIN) TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)]

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SAFETY COATED ASPIRIN (ASPIRIN) TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)]
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NDC 63941-441-01
Set ID 1fe911d3-4e7d-4af1-87e9-9657f91e4f83
Category HUMAN OTC DRUG LABEL
Packager Valu Merchandisers Company (Best Choice)
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug 

  • Purpose

    Pain reliever 

  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
  • 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:  

    • facial swelling
    • hives
    • 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 

    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

    • you experienece 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
      • ringing in the ears or a loss of hearing occurs
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • any new symptoms appear
      • redness or swelling is present in the painful area

    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 the delivery. 

    Keep out of reach of children.

    In case of 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: do not use unless directed by a doctor 
  • Other information

    • store at controlled room temperature 15º-30º C (59º-86º F)
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C Red # 40 Aluminum lake,FD&C Yellow # 6 Aluminum Lake,  iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,  simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

  • Questions or comments?

    call toll free 1-877-753-3935

  • Principal Display Panel

    Compare to the active ingredient in St. Joseph® Aspirin  †

    † This product is not manufactured or distributed by McNeil Consumer & Speciality Pharmaceuticals, owner of the registered trademark ST. JOSEPH® 81 mg

    See New Warnings Information

    SAFETY COATED ASPIRIN

    Adult Low Strength, 81 mg (NSAID)* Aspirin Regimen**

    **Ask your doctor before taking this product on a regular basis

    • Pain reliever
    • Protects against stomach upset

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

  • Product Label

    Valu Merchandisers BEST CHOICE

    Enteric coated Aspirin 81 mg

  • INGREDIENTS AND APPEARANCE
    SAFETY COATED ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-441
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (enteric coated peach) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code heart;328
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-441-011 in 1 CARTON
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/21/2010
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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