Label: ASPIRIN tablet

  • NDC Code(s): 10135-729-62
  • Packager: Marlex Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active ingredient (in each tablet)

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever

  • 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

  • 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 useif 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
    · You have not been drinking fluids
    · You have lost a lot of fluid due to vomiting or diarrhea

    Ask a doctor or a pharmacist before use if you are

    · Taking a prescription drug for diabetes, gout, or arthritis
    · Under a doctor’s care for any serious condition
    · Taking any other drug

    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 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 problem 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: consult a doctor

  • Other Information:

    · Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
    · Use by expiration date on package

  • Inactive Ingredients:

    Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin

  • Questions?

    Adverse Drug Event Call: (888) 582 1953or Email: drugsafety@marlexpharm.com

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev.1 09/21 AA

    www.marlexpharm.com

    NDC 10135-0729-62

    Label Front

    Label Back

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-729
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIACETIN (UNII: XHX3C3X673)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code S;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-729-62120 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/01/2021
    Labeler - Marlex Pharmaceuticals Inc. (782540215)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!