ASPIRIN 325 MG EC (ASPIRIN) TABLET [NUCARE PHARMACEUTICALS, INC.]

ASPIRIN 325 MG EC (ASPIRIN) TABLET [NUCARE PHARMACEUTICALS, INC.]
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NDC 68071-3189-1, 68071-3189-2, 68071-3189-3, 68071-3189-5, 68071-3189-6, 68071-3189-9
Set ID 4eb78632-dc64-5d99-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Aspirin USP, 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Pain Reliever/Fever Reducer

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  • INDICATIONS & USAGE

    temporarily relieves

    • headache
    • menstrual pain
    • minor pain of arthritis
    • muscle pain
    • toothache
    • pain and fever of colds
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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 prodcut, 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.

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  • OTHER SAFETY INFORMATION

    Allergy alert: Aspirin may cause a severe allergic reaction which may include

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
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  • OTHER SAFETY INFORMATION

    Stomach bleeding warning: This prodcut 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 (ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    Drug Facts continued on back of label

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  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

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  • ASK DOCTOR

    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
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

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

    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 lasta more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs

    These could be sings of a serious condition

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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.

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  • KEEP OUT OF REACH OF CHILDREN

    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

    • adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • store at room temperature 15°-30ºC (59°-86°F)
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  • Inactive ingredients

    croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

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  • Questions or comments?

    Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

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  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325 MG EC 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3189(NDC:69618-015)
    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
    POVIDONE (UNII: FZ989GH94E)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code AP;110
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68071-3189-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    2 NDC:68071-3189-1 21 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    3 NDC:68071-3189-5 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    4 NDC:68071-3189-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    5 NDC:68071-3189-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    6 NDC:68071-3189-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/01/2015
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    Name Address ID/FEI Business Operations
    NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3189)
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