Label: ASPIRIN - aspirin tablet, extended release

  • NDC Code(s): 51645-717-08
  • Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID*)

    * nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever

    Close
  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
    Close
  • 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:
    • have  had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • are age 60 or older
    • have 3 or more alcoholic drinks every day while using this product

    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 have asthma
    • you are taking a diuretic
    • you have not been drinking fluids
    • you have lost a lot of fluid due to vomiting or diarrhea

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug
    • under a doctor's care for any serious condition


    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleedin

                    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
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.
    Close
  • 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
    Close
  • Other information

    • Do not use if imprinted safety seal under cap is broken or missing.
    • store at 250C (770 F) excursions permitted between 150-300C (590-860 F)
    Close
  • Inactive ingredients:

    Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, D and C Yellow #10 Aluminum Lake, Iron Oxide Ochre, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polysorbate 80, Simethicone, Sodium Hydroxide, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate.
    Close
  • Questions?

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

    Close
  • Principal Display Panel

    PlusPHARMA
    ASPIRIN
    81 mg
    NSAID
    PAIN RELIEVER
    LOW DOSE ASPIRIN REGIMEN
    • Safety Coated-Enteric Coated
    • Delayed Release Aspirin Tablets
    • Small, Easy-to-Swallow Tablets
    *Compare to the active ingredient in Bayer Low Dose
    *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer Low Dose.
    120 TABLETS
    • 81 mg each
      Untitled.jpg
      Untitled1.jpg
    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  
    aspirin tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51645-717
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND (YELLOW) Size 7mm
    Flavor Imprint Code RAISED;HEART
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51645-717-08 120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/10/2013
    Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270)
    Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270)
    Close