Label: ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 62732-8005-1
  • Packager: Yichang Humanwell Pharmaceutical Co. Ltd.
  • 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 May 8, 2017

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

    • 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 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 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

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  • DO NOT USE

    Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

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  • ASK DOCTOR

    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 have asthma
    • you are taking a diuretic
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • gout
    • diabetes
    • arthritis
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  • STOP USE

    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: •feel faint •have bloody or black stools •vomit blood •have stomach pain that does not get better
    • any new symptoms occur
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • ringing in the ears or a loss of hearing occurs

    These could be signs of a serious illness.

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  • PREGNANCY OR BREAST FEEDING

    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.

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  • OVERDOSAGE

    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, 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

    • store at 15-25ºC (59-77ºF)
    • protect from heat, humidity, and light
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  • Inactive ingredients

    colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, ferrosoferric oxide, glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, povidone, pregelatinized starch, shellac, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, and titanium dioxide.

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  • PRINCIPAL DISPLAY PANEL

    Quantity: 70,000 Tablets

    NDC No.: 62732-8005-1

    8005

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62732-8005
    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
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code 81E
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62732-8005-1 70000 in 1 BAG; Type 0: Not a Combination Product 12/14/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 12/14/2016
    Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)
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