VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH (ASPIRIN) TABLET [AJES PHARMACEUTICALS,LLC]

VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH (ASPIRIN) TABLET [AJES PHARMACEUTICALS,LLC]
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NDC 42787-102-12
Set ID b4a9f50f-9eda-4d8f-91be-4053ee6ce0ec
Category HUMAN OTC DRUG LABEL
Packager Ajes Pharmaceuticals,LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    nonsteroidal antiinflammatory drug

  • INACTIVE INGREDIENT

    Inactive Ingredients Hydroxypropylmethyl cellulose, polyethylene glycol, starch, talc, titanium dioxide

  • PURPOSE

    Purpose

    Pain reliever /  Fever reducer

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Uses provides temporary relief of: headache pain and fever of colds - muscle pain - toothache - minor pain of arthritis

  • WARNINGS

    Warnings

    Do not use - if you have ever had an allergic reaction to any other pain relievers/fever reducers.

    Reyes 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 or 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  sever allergic  reaction which may include : facial swelling - asthma (wheezing) - shock - hives

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you are- 60 years of age or older - have had stomach ulcer bleeding problems - take a blood thinner (anticoagulant) or steroid drug - take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, others) - have 3 or more alcoholic drinks everyday while using this product - take more or for a longer time than directed

  • DOSAGE & ADMINISTRATION

    Directions - drink a full glass of water with each dose - Adults and children 12 years of age and over: take 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. Children under 12: consult a doctor

  • NURSING MOTHERS

    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 or complications during delivery

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    VALUE PHARMAPAIN RELIEVER  EXTRA STRENGTH
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg  in 325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white color) Scoreno score
    ShapeROUND (Round Tablet) Size11mm
    FlavorImprint Code C10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42787-102-121 in 1 CARTON
    1325000 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/01/2012
    Labeler - Ajes Pharmaceuticals,LLC (159945393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ajes Pharmaceuticals,LLC159945393manufacture(42787-102) , relabel(42787-102) , repack(42787-102)

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