ADULT LOW DOSE (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [SAFREL PHARMACEUTICALS, LLC.]

ADULT LOW DOSE (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [SAFREL PHARMACEUTICALS, LLC.]
PDF | XML

NDC 71309-103-01, 71309-103-02, 71309-103-25, 71309-103-30, 71309-103-50, 71309-103-60, 71309-103-65
Set ID 87401db3-7162-b48b-e053-2a95a90ac98f
Category HUMAN OTC DRUG LABEL
Packager Safrel Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)                          Purpose

    Aspirin 81 mg (NSAID)* ........................................ Pain reliever

    *nonsteroidal anti-inflammatory drug

    Close
  • Uses

    • temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
    • ask your doctor about other uses for 81 mg Aspirin
    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
    • shock
    • facial swelling
    • asthma (wheezing)

    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 are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • you have asthma
    • 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

    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

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
    • an allergic reaction occurs.

       Seek medical help right away.

    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling present in the painful area
    • new symptoms occur

    These could be sign of a serious condition

    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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    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

    • store at room temperature 15-30ºC (59-86ºF)
    • read all product information before using.
    • Keep this box for important information
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Close
  • Inactive ingredients

    Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

    Close
  • Questions or comments?

    Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

    Close
  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information & Directions

    Compare to Bayer® Low Dose Aspirin active ingredients†

    † This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer® Low Dose Aspirin.

    Aspirin Delayed Release Tablets, 81 mg

    cartonbottle

    Close
  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE 
    aspirin 81 mg tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-103
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71309-103-25 25 in 1 BOX 06/05/2017
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    2 NDC:71309-103-50 50 in 1 BOX 06/05/2017
    2 2 in 1 POUCH; Type 0: Not a Combination Product
    3 NDC:71309-103-02 2 in 1 POUCH 06/05/2017
    3 2 in 1 POUCH; Type 0: Not a Combination Product
    4 NDC:71309-103-01 1000 in 1 BOTTLE 06/05/2017
    4 NDC:71309-103-65 365 in 1 BOTTLE
    4 NDC:71309-103-30 30 in 1 BOTTLE
    4 1 in 1 CARTON; Type 0: Not a Combination Product
    5 NDC:71309-103-60 1 in 1 CARTON 06/05/2017
    5 60 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 02/09/2016
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)
    Close

Related Drugs