Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 11788-301-05
  • Packager: AiPing Pharmaceutical 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 8, 2015

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

  • Active ingredient (in each tablet)

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

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  • Purpose

    Pain reliever

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  • Uses

    Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Ask your doctor about other uses for Enteric Coated 81 mg Aspirin.

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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 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

    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

    an allergic reaction occurs. Seek medical right away.
    you experience any of the following signs of stomach bleeding:
    o
    feel faint
    o
    vomit blood
    o
    have bloody or black stools
    o
    have stomach pain that does not get better
    o
    pain gets worse or lasts more than 10 days
    o
    redness or swelling is present
    o
    new symptoms occur
    o
    ringing in the ears or a 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of 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 not to exceed 48 tablets in 24 hours unless directed by a doctor
    children under 12 years: consult a doctor
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  • Other Information

    save carton for full directions and warnings
    store at room temperature
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  • Inactive Ingredients

    Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, acrylic acid, triethyl citrate, titanium dioxide, talc, FD&C Yellow No.5

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  • Questions or comments?

    Call toll free 1-844-374-0016 Monday through Friday 9AM-5PM

    Manufactured for:
    AiPing Pharmaceutical Inc.
    Hauppauge, NY11788

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11788-301
    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
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 68401960MK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11788-301-05 1 in 1 CARTON
    1 50 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/30/2014
    Labeler - AiPing Pharmaceutical Inc. (079674526)
    Registrant - AiPing Pharmaceutical Inc. (079674526)
    Establishment
    Name Address ID/FEI Business Operations
    Anshi Pharmaceutical (Zhongshan) Inc. 528101821 ANALYSIS(11788-301) , MANUFACTURE(11788-301) , LABEL(11788-301) , PACK(11788-301)
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