Label: ADULT LOW DOSE ASPIRIN - aspirin tablet, delayed release

  • NDC Code(s): 16103-356-09, 16103-356-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • 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 July 19, 2011

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

  • Active Ingredient (in each tablet):

    Aspirin 81mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever
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  • INDICATIONS & USAGE

    • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
    • ask your doctor about other uses for this product.
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  • WARNINGS

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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
    • asthma (wheezing)
    • facial swelling
    • 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

    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
    These could be signs of a serious condition.

    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.
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  • 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 while symptoms persist. Do not to exceed 48 tablets in 24 hors or as directed by a physician
    • children under 12 years: consult a physician
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  • 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
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  • Inactive ingredients: crosscarmellose Sodium, D&C yellow# 10 Lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.
  • Questions?

    Adverse drug event call: (866) 562-2756
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  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-356
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color yellow (YELLOW COLOR) Score no score
    Shape ROUND (ROUND TABLET) Size 8mm
    Flavor Imprint Code PH023
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16103-356-09 1 in 1 CARTON
    1 120 in 1 BOTTLE, PLASTIC
    2 NDC:16103-356-11 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/12/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceuticals, Inc. 557054835 manufacture, pack, label
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