Label: ASCURIN- aspirin capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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  • Drug Facts

  • Active ingredient (per capsule)

    Aspirin (NSAID*) 81mg

    Purpose

    pain reliever-fever reducer *nonsteriodal anti-inflammatory drug

  • Use

    For the temporary relief of minor aches and pains associated with a cold, headache, toothache, muscular aches, backache, the premenstrual and menstrual periods, for the minor pain from arthritis and to reduce fever

  • 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

    • 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 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 are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or 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:
    • 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
    • any new symptoms occur
    • ringing in the ears or 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.

  • Directions

    • Adults: Drink a full glass of water with each dose.
    • Adults and children 12 years and over: Take 5-8 capsules every 4 hours not to exceed 49 capsules in 24 hours unless directed by a doctor.
    • Children under 12 years of age: consult a doctor.
    • See your doctor for other uses of aspirin, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
  • Other information

    Do not use the product if the bottle seal inside the bottle lid is broken.

  • Inactive ingredients

    Curcumin, Hydroxypropyl Methylcellulose, Orange Oil, Polyvinylpyrrolidone.

  • Questions or Comments?

    Call (609) 902-7128 9:00 AM – 7:00 PM E.T. Monday-Friday

  • Package Labeling:

    Outer Package0Inner Package0

  • INGREDIENTS AND APPEARANCE
    ASCURIN 
    aspirin capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83607-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CURCUMIN (UNII: IT942ZTH98)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    Product Characteristics
    Colorwhite (Colorless) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83607-002-001 in 1 BOX12/10/2023
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/10/2023
    Labeler - Healthdoc LLC (013084196)