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
  • 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 6, 2022

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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 finalpart33504/01/2014
    Labeler - Unifirst First Aid Corporation (832947092)
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