Label: MEDIQUE DIOTAME- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 47682-210-13, 47682-210-33, 47682-210-64, 47682-210-83, view more
    47682-210-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Bismuth Subsalicylate 262 mg

    (each tablet contains 102 mg salicylate)

  • PURPOSE

    Purpose

    antidiarrheal/antacid

  • INDICATIONS & USAGE

    Uses

    relieves

    • traveler's diarrhea
    • diarrhea
    • upset stomach reliever due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching
      • fullness
  • 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: Contains salicylate. Do not take if you are:

    • allergic to salicylates (including aspirin)
    • taking other salicylate products

    Do not use if you have

    • bloody or black stool
    • an ulcer
    • a bleeding problem

    Ask a doctor before use if you have​

    • fever
    • mucus in the stool

    Ask a doctor or pharmacist if you are taking any drug for

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis

    When using this product a temporary and harmless darkening of the tongue and/or stool may occur.

    Stop use and ask a doctor if

    • symptoms get worse or lasts more than 2 days
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • chew or dissolve in mouth
    • do not swallow tablets whole
    • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea

    Adults and children: (12 years and over)

    • chew 2 tablets every 1/2 to 1 hour as needed
    • do not exceed 16 tablets in 24 hours
    • use until diarrhea stops but not more than 2 days

    ​Children under 12 years:

    ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • phenylketonurics: contains phenylalanine 1.1mg per tablet
    • calcium content per tablet: 73 mg
    • store at room temperature 59°-86°F (15°-30°C)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medique Diotame Label

    Medique®

    Diotame

    Bismuth Subsalicylate

    Chewable Tablets

    Upset Stomach/Diarrhea • Bismuth Subsalicylate 262 mg

    Tamper Evident Unit Dose Packets

    Medique

  • INGREDIENTS AND APPEARANCE
    MEDIQUE DIOTAME 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code RH;046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-210-8315 in 1 BOX04/01/2014
    1NDC:47682-210-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-210-3350 in 1 BOX04/01/2014
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-210-13250 in 1 BOX04/01/2014
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-210-6412 in 1 BOX04/01/2014
    42 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:47682-210-992 in 1 PACKET; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/01/2014
    Labeler - Unifirst First Aid Corporation (832947092)
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