Label: ASPIRIN tablet, coated

  • NDC Code(s): 49483-011-00, 49483-011-01, 49483-011-10
  • Packager: TIME CAP LABS INC
  • 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 22, 2021

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 ingredients corn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    11R-TCL-Aspirin 325 mg-bulk label11R-TCL-Aspirin 325 mg-bottle label-1000s11R-TCL-Aspirin 325 mg-bottle label-100s

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-011-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2014
    2NDC:49483-011-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2014
    3NDC:49483-011-00100000 in 1 CARTON; Type 0: Not a Combination Product04/02/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/02/2014
    Labeler - TIME CAP LABS INC (037052099)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS INC037052099manufacture(49483-011)