Label: ASPIRIN tablet

  • 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 December 30, 2017

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

  • Active Ingredient (in each tablet)

      Aspirin (NSAID *) 325 mg
    *nonsteroidal anti-inflammatory drug 

  • Purpose

    Pain Reliever / fever reducer 

  • Uses

    Temporarily relieves minor aches and pains associated with:
    headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

  • Warnings

    Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of 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, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:   This 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 thinner (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 have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

  • 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:

    under a doctor's care for any serious condition;  taking any other drug

  • WHEN USING

    When using this product: take with food or milk if stomach upset occurs

  • Stop use and ask a doctor if

    Stop use and ask a doctor if
    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 more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important 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

    Keep out of reach of children.  In case of overdose, get medical help or

    contact a Poison Control Center right away.

  • Directions

    do not use more than directed

    the smallest effective dose should be used

    drink a full glass of water with each dose

    do not take longer than 10 days, unless directed by a doctor


  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older) Take 1 or 2 tablets with

    water every 4 hours as needed.  Do not take more than 12 tablets in 24

    hours, or as directed by a doctor.

    Children under 12 years:   Do not give to children under 12 years of age.

  • STORAGE AND HANDLING

    Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid

    excessive heat and humidity;  tamper evident sealed packets;

    Do not use any opened or torn packets

  • Inactive Ingredients

    hypromellose, polyethylene glycol, propylene glycol, corn starch

  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Clevelad Str Suite 400, Clearwater, FL 33755

  • PRINCIPAL DISPLAY PANEL

    Aspirin 325 mg
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0011-12 in 1 PACKAGE; Type 0: Not a Combination Product04/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/23/2010
    Labeler - Genuine First Aid LLC (619609857)