Label: ASPIRIN tablet, coated

  • NDC Code(s): 57344-018-11, 57344-018-19, 57344-018-21
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 13, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID) *

    * nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves:

    headache
    muscle pain
    toothache
    menstrual pain
    pain and fever of colds
    minor pain of arthritis

  • 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 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 are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:

    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • 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 for more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs

    These could be signs 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 right away (1-800-222-1222).

  • SPL UNCLASSIFIED SECTION

  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: consult a doctor
  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information and warnings
  • Inactive ingredients

    corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    RESTORE u

    NDC 57344-018-11

    †COMPARE TO THE ACTIVE INGREDIENT IN BAYER® ASPIRIN

    REGULAR STRENGTH

    Coated for Easy Swallowing

    Aspirin
    Pain Reliever / Fever Reducer
    (NSAID)

    Actual Size

    100 COATED TABLETS - 325 MG EACH

    image description

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-018-111 in 1 CARTON10/01/2018
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:57344-018-211 in 1 CARTON09/01/2017
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:57344-018-19300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/01/2017
    Labeler - AAA Pharmaceutical, Inc. (181192162)