Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 54738-559-03, 54738-559-12, 54738-559-25
  • Packager: Richmond Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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, 2017

If you are a consumer or patient please visit this version.

  • 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

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
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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 signs of  Reye’s syndrome, a rare but serious illness.

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

    • hives
    • asthma (wheezing)
    • shock
    • facial swelling

      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
    • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
    • takes more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product.

      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, lever 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
    • taking any other drug
    • under a doctor’s care for any serious condition

      Stop use and ask a doctor if

    • you experiences 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 in the painful area
    • any new symptoms appear
    • ringing in the ears or a 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.

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  • 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 older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
    • Children under 12 years: ask a doctor
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  • Other Information

    • store at 15-30 °C (59-86 °F)
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  • Inactive Ingredients

    croscarmellose sodium, D&C Yellow #10 (Al-Lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

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  • Questions or Comments

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

    Safer for your stomach than pain or Buffered Aspirin

    call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC: 54738-559-12– 120 Tablets

    image2

    NDC: 54738-559-25 - 240 Tablets

    NDC: 54738-559-03 - 1000 Tablets

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-559
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AP;121
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54738-559-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2015
    2 NDC:54738-559-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2015
    3 NDC:54738-559-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 04/01/2015
    Labeler - Richmond Pharmaceuticals, Inc. (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 manufacture(54738-559)
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