Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 11788-302-04
  • 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 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    minor arthritis pain
    toothache
    menstrual pain
    colds
    or as recommended by a doctor
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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
    shock
    facial swelling
    asthma (wheezing)

    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 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

    diabetes
    gout
    arthritis

    Stop use and ask a doctor if
    an allergic reaction occurs. Seek medical help 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
    pain gets worse or lasts more than 10 days
    redness or swelling is present
    any new symptoms occur
    ringing in the ears or a 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.

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  • 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

    adults and children 12 years of age and over: take 1 or 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose
    do not take more than 12 tablets in 24 hours unless directed by a doctor
    children under 12 years: ask a doctor.

    Other information

    Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
    store below 25ºC (77ºF)
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  • Inactive Ingredients

    Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, methacrylic acid copolymer, sodium lauryl sulfate, polysorbate, triethyl citrate, titanium dioxide, talc, FD&C red No.40, FD&C yellow No.5, FD&C yellow No.6, Aluminum Oxide

    Questions or comments

    Call Toll Free 1-888-952-0050 Monday through Friday 9AM-5PM

    Manufactured for:

    A&Z Pharmaceutical Inc.
    Deer Park, NY 11729

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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:11788-302
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 68401960MK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11788-302-04 1 in 1 CARTON
    1 40 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 01/31/2014
    Labeler - AiPing Pharmaceutical, Inc. (079674526)
    Registrant - AiPing Pharmaceutical, Inc. (079674526)
    Establishment
    Name Address ID/FEI Business Operations
    Anshi Pharmaceutical (Zhongshan) Inc. 528101821 MANUFACTURE(11788-302) , ANALYSIS(11788-302) , LABEL(11788-302) , PACK(11788-302)
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