Label: ASCRIPTIN REGULAR STRENGTH BUFFERED ASPIRIN- aspirin tablet, film coated 

  • Label RSS
  • NDC Code(s): 0067-0149-10, 0067-0149-22
  • Packager: Novartis Consumer Health, Inc.
  • 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 01/10

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

  • Active ingredient(in each tablet)  

    Buffered aspirin equal to 325 mg aspirin (NSAID)*

    (buffered with aluminum hydroxide, calcium carbonate, and magnesium hydroxide)

    *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 associated with:
      • arthritis
      • headache
      • muscular aches
      • toothache
      • premenstrual & menstrual cramps
      • cold
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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 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 an NSAID (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

    • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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  • Ask a doctor before use if you have

    •  stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • heart or kidney disease
    • taken a diuretic
    • reached age 60 or older
    • asthma
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  • Ask a doctor or pharmacist before use if you are taking:

    • any other drug containing an NSAID (prescription or nonprescription)
    • a blood thinning (anticoagulant) or steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor’s care for any serious condition

     

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  • Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
    • stomach pain or upset gets worse or lasts
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear

    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.

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  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2  tablets every 4 hours while symptoms persist; not more than 12 tablets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • each tablet contains: calcium 70 mg, and magnesium 10 mg
    • store at controlled room temperature 200 -  250 C (680 -  770 F)
    • protect from moisture and excessive heat 
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  • Inactive ingredients

    Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, granular sugar, hypromellose, magnesium stearate, mannitol, methylparaben, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, sodium saccharin, sorbitol, talc, titanium dioxide

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  • Questions or comments?  

    1-800-452-0051

    Novartis Consumer Health, Inc.

    200 Kimball Drive

    Parsippany, NJ 07054-0622

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  • Package Label

    Ascriptin

    Ascriptin

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  • INGREDIENTS AND APPEARANCE
    ASCRIPTIN  REGULAR STRENGTH BUFFERED ASPIRIN
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-0149
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALUMINUM HYDROXIDE  
    CALCIUM CARBONATE  
    MAGNESIUM  
    MAGNESIUM HYDROXIDE  
    CARNAUBA WAX  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    SUCROSE  
    HYPROMELLOSE  
    MAGNESIUM STEARATE  
    MANNITOL  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLENE GLYCOL  
    SHELLAC  
    SACCHARIN SODIUM  
    SORBITOL  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code ASCRIPTIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-0149-10 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:0067-0149-22 1 in 1 CARTON
    2 225 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 09/24/2009
    Labeler - Novartis Consumer Health, Inc. (879821635)
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