Label: ASPIRIN LOW DOSE SAFETY COATED- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 1, 2019

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug 

  • Purpose

    Pain reliever 

  • Uses

    •
    for the 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 safety coated 81 mg aspirin
  • 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
    •
    shock
    •
    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

    •
    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 have asthma
    •
    you are taking a diuretic 

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    •
    gout
    •
    diabetes
    •
    arthritis 

    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. 
    •
    new symptoms occur
    •
    pain gets worse or lasts more than 10 days
    •
    redness or swelling is present
    •
    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

    •
    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: do not use
  • Other information

    •
    store at controlled room temperature 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    anhydrous lactose**, black iron oxide**, brown iron oxide**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polysorbate 80**,  potassium hydroxide**, pregelatinized starch**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

    **contains one or more of these ingredients 

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    ‡Aspirin Regimen

    Low Dose Safety Coated

    Aspirin 81 mg

    Pain Reliever (NSAID)

    †Compare to active ingredient in Bayer® Low Dose Aspirin

    Enteric Coated Tablets

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

    ‡Aspirin is not appropriate for everyone, so be sure you talk to your doctor before you begin an aspirin regimen.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

    Ditributed by: Geiss, Destin & Dunn, Inc.

    Peachtree City, GA  30269

    Relabeled by: Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-882-72
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE SAFETY COATED
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-882(NDC:50804-227)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code E;T81;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-882-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
    2NDC:63187-882-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
    3NDC:63187-882-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
    4NDC:63187-882-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
    5NDC:63187-882-72120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/15/2013
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-882) , RELABEL(63187-882)
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