ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REMEDYREPACK INC.]

ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REMEDYREPACK INC.]
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NDC 70518-0838-0, 70518-0838-1
Set ID f789d28d-6087-453a-b85e-ef0aad5a033d
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number PART343
  • 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
    • ask your doctor about other uses for aspirin
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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 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 your are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
    • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking a prescription drug for diabetes, gout or 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
    • an allergic reaction occurs. Seek medical help right away
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • 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.

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  • Directions

    • drink a full glass of water with each dose
    • swallow whole, do not chew or crush
    • do not exceed recommended dose
    • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • store at controlled room temperature
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  • Inactive ingredients

    anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum
    lake, hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

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  • PRINCIPAL DISPLAY PANEL

    DRUG: Adult Low Dose Enteric Coated Aspirin

    GENERIC: Aspirin

    DOSAGE: TABLET, DELAYED RELEASE

    ADMINSTRATION: ORAL

    NDC: 70518-0838-0

    NDC: 70518-0838-1

    COLOR: yellow

    SHAPE: ROUND

    SCORE: No score

    SIZE: 7 mm

    IMPRINT: T81

    PACKAGING: 30 in 1 BOTTLE, PLASTIC

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • ASPIRIN 81mg in 1

    INACTIVE INGREDIENT(S):

    • ANHYDROUS LACTOSE
    • DIMETHICONE
    • SHELLAC
    • PROPYLENE GLYCOL
    • SODIUM LAURYL SULFATE
    • BROWN IRON OXIDE
    • CELLULOSE, MICROCRYSTALLINE
    • TALC
    • TITANIUM DIOXIDE
    • TRIETHYL CITRATE
    • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
    • HYPROMELLOSES
    • POTASSIUM HYDROXIDE
    • POLYSORBATE 80
    • CROSCARMELLOSE SODIUM
    • SODIUM HYDROXIDE
    • D&C YELLOW NO. 10
    • MINERAL OIL
    • SILICON DIOXIDE
    • FERROSOFERRIC OXIDE
    • STARCH, CORN

    MM1

    MM2

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  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ENTERIC COATED ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0838(NDC:57896-985)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code T81
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70518-0838-0 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017
    2 NDC:70518-0838-1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/07/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/13/2017
    Labeler - REMEDYREPACK INC. (829572556)
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