Label: ASPIRIN 5 GRAIN- aspirin tablet

  • NDC Code(s): 69103-2501-5, 69103-2501-6
  • Packager: Provision Medical Products
  • 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 March 31, 2015

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

  • INDICATIONS & USAGE

    Uses:

    temporarily relieves pains due to:•headache • minor pain of arthritis•muscular aches • temporarily reduces fever•common cold

    Close
  • 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

    SPECIFICALLY DIRECTED TO DO SO BY

    A DOCTOR, BECAUSE IT MAY CAUSE

    PROBLEMS IN THE UNBORN CHILD OR

    COMPLICATIONS DURING DELIVERY.

    Close
  • 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. Prompt medical attention is

    critical for adults as well as for children

    even if you do not notice any signs or

    symptoms.

    Close
  • WARNINGS

    Warnings:

    Reye's syndrome: Children and teenagers should not

    use this medicine for chicken pox or -u symptoms

    before a doctor is consulted about Reye's syndrome, a

    rare but serious illness reported to be associated with

    aspirin.

    Alcohol Warning: If you consume 3 or more alcoholic

    drinks every day, ask your doctor whether you should

    take aspirin or other pain relievers/fever reducers.

    Aspirin may cause stomach bleeding.

    Do not use:

    if you are allergic to aspirin

    with any other pain reliever/fever reducer

    if you have ever had an allergic reaction to any

    other pain reliever/fever reducer

    for pain for more than 10 days or for fever for

    more than 3 days unless directed by a doctor

    with any other product containing aspirin

    Ask a doctor before using if you have:

    asthma • gastric ulcers • bleeding problems

    stomach problems (such as heartburn, upset stomach

    or stomach pain)

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for:

    • anticoagulation

    (thinning of blood)

    • diabetes • gout • arthritis

    Stop use and ask a doctor if:

    ringing in the ears or loss of hearing occurs

    pain or fever persists or gets worse

    new symptoms occur

    redness or swelling is present

    When using this product do not exceed

    recommended dose

    Close
  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older take 2 tablets every 4 to 6hours as

    needed, do not exceed 12 tablets in 24 hours, or as directed by

    a doctor.

    Children under 12 years consult a

    doctor.

    Do not use more than directed

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    corn starch, povidone, silicon dioxide

    and stearic acid.

    Close
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-ASPIRIN 325 MG

    Close
  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 5 GRAIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2501
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE K30 (UNII: U725QWY32X)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white (SNOW WHITE) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69103-2501-5 250 in 1 CARTON 04/03/2015
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:69103-2501-6 100 in 1 CARTON 04/03/2015
    2 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/31/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    Name Address ID/FEI Business Operations
    Ultraseal Corporation 085752004 pack(69103-2501)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2501)
    Close