Label: MINIPRIN - aspirin tablet, coated

  • NDC Code(s): 49483-054-00, 49483-054-10, 49483-054-12
  • Packager: TIME CAP LABORATORIES, INC
  • 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 May 7, 2012

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

  • ACTIVE INGREDIENT

    In each tablets Aspirin 81 mg (NSAID*)

    Close
  • PURPOSE

    PAIN RELIEVER
    Close
  • INDICATIONS & USAGE

    INDICATIONS AND USAGE:

    Pain Reliever – temporarily relieves minor aches and pains.  For other uses, see your doctor. Do not use for more than 10 days without consulting your doctor because serious side effects may occur.

    Close
  • 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: facial swelling, shock, hives, 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.

    Close
  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    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.

    Close
  • INACTIVE INGREDIENT

    acetylated monoglycerides, anhydrous lactose, colloidal silicon dioxice, croscarmellose sodium, D-CYellow no.10 aluminum lake, hypromellose, hypromellose phthalate, iron oxide yellow (iron oxide ochre), microcrystalline cellulose, mineral oil, polyethylene glycol (PEG) 80, titantium dioxide

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

    Close
  • PRINCIPAL DISPLAY PANEL

    130labelEnter section text here

    Close
  • INGREDIENTS AND APPEARANCE
    MINIPRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-054
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code 8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-054-12 120 in 1 BOTTLE, PLASTIC
    2 NDC:49483-054-10 1000 in 1 BOTTLE, PLASTIC
    3 NDC:49483-054-00 100000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/07/2012
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABORATORIES, INC 037052099 manufacture
    Close