Label: PLUS PHARMA NSAID ASPIRIN - aspirin tablet

  • NDC Code(s): 51645-716-01, 51645-716-10
  • Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharma
  • 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 March 27, 2006

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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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    for temporary relief of



    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • menstrual cramps
    • minor aches and pains
    • temporarily reduces fever
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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 a nonsteroidal anti-inflammatory drug (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

    with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.


    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

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for



    • anticoagulation (blood thinning)
    • 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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • ringing in the ears or hearing loss occurs
    • redness or swelling is present

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use Aspirin during 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 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
    • Do not take more than directed
    • Adults and children 12 years and older: take 1 to 2 tablets every 4 hours, or 3 tablets every 6 hours as needed. Do not take more than 12 tablets in 24 hours
    • Children under 12: ask a doctor
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  • Other information

    • Do not use if imprinted safety seal under cap is broken or missing.
    • Store at room temperature
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  • Inactive ingredients

    Corn Starch, Povidone.


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  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

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  • Principal Display Panel

    PlusPHARMA

    ASPIRIN 325 mg

    NSAID

    SAFE, FAST PAIN RELIEF FROM:


    • HEADACHES
    • COMMON ACHES AND PAINS

    PAIN RELIEVER/FEVER REDUCER

    *Compare to the Active Ingredient in Genuine Bayer® Aspirin

    *Plus Pharma is not affiliated with the owner of the registered trademark Bayer®

    100 TABLETS 325 mg each

    jlirorfed.jpgkytheked.jpg

    PlusPHARMA

    ASPIRIN 325 mg

    NSAID

    SAFE, FAST PAIN RELIEF FROM:


    • HEADACHES
    • COMMON ACHES AND PAINS

    PAIN RELIEVER/FEVER REDUCER

    *Compare to the Active Ingredient in Genuine Bayer® Aspirin

    *Plus Pharma is not affiliated with the owner of the registered trademark Bayer®

    1000 TABLETS 325 mg each


    luyehed.jpg


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  • INGREDIENTS AND APPEARANCE
    PLUS PHARMA NSAID ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51645-716
    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, CORN (UNII: O8232NY3SJ)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score no score
    Shape ROUND (bi-convex tablet) Size 10mm
    Flavor Imprint Code Aspirin;GPI
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51645-716-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:51645-716-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 03/27/2006
    Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
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