Label: ASPIRIN tablet, coated

  • NDC Code(s): 37808-174-32, 37808-174-53, 37808-174-73
  • Packager: H-E-B
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 7, 2024

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Aspirin 325 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever

  • INDICATIONS AND USAGE

    Uses

    for the temporary relief of minor aches and pains due to

    • headache
    • colds
    • menstrual pain
    • muscle pain
    • toothache
    • minor pain of arthritis

    or as directed by your doctor

  • WARNINGS

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

  • DO NOT USE

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
  • 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 asthma
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have not been drinking fluids
    • you have lost a lot of fluid due to vomiting or diarrhea
  • ASK DOCTOR/PHARMACIST

    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

    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

    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 painfull area

    any new symptoms appear

    ringing in the ears or a loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    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 casue problems in the unborn child or complications during delivery.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    drink a full glass of water with each dose

    • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredientscorn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    heb-aspirin-500s-labelheb-aspirin-300s-labelheb-aspirin-100s-label

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-174
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-174-73100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    2NDC:37808-174-32300 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    3NDC:37808-174-53500 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2024
    Labeler - H-E-B (007924756)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS INC037052099manufacture(37808-174)