FDA.reportPublic FDA data

Medique Diotame

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:12:45

Label at a glance#

ProductMedique Diotame
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

OTC - PURPOSE SECTION

Purpose

antidiarrheal/antacid

INDICATIONS & USAGE SECTION

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach reliever due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching
    • fullness

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have​

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

Medique Diotame Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique®

Diotame

Bismuth Subsalicylate

Chewable Tablets

Upset Stomach/Diarrhea • Bismuth Subsalicylate 262 mg

Tamper Evident Unit Dose Packets

MediqueMedique

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN16
308761bismuth subsalicylate 262 MG Chewable TabletSCD16

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-210-13Medique Diotame250 in 1 BOXTABLET, CHEWABLE25016
47682-210-13Medique Diotame2 in 1 PACKETTABLET, CHEWABLE216
47682-210-33Medique Diotame2 in 1 PACKETTABLET, CHEWABLE216
47682-210-33Medique Diotame50 in 1 BOXTABLET, CHEWABLE5016
47682-210-64Medique Diotame2 in 1 PACKETTABLET, CHEWABLE216
47682-210-64Medique Diotame12 in 1 BOXTABLET, CHEWABLE1216
47682-210-83Medique Diotame15 in 1 BOXTABLET, CHEWABLE1516
47682-210-99Medique Diotame2 in 1 PACKETTABLET, CHEWABLE216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR12
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YE2
ACACIAINACTIVE INGREDIENT5C5403N26O2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR12
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K2
DEXTRATESINACTIVE INGREDIENTG263MI44RU2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-21047682-210-99, 47682-210-83, 47682-210-33, 47682-210-13, 47682-210-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
CALCIUM CARBONATEH0G9379FGKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
D&C RED NO. 272LRS185U6KIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MALTODEXTRIN7CVR7L4A2DIACT
ACACIA5C5403N26OIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
ndc (package): 47682-210-83
ndc (package): 47682-210-99
ndc (package): 47682-210-33
ndc (package): 47682-210-13
ndc (package): 47682-210-64
ndc (product): 47682-210
ndc11 (package): 47682021033
ndc11 (package): 47682021013
ndc11 (package): 47682021083
ndc11 (package): 47682021064
ndc11 (package): 47682021099
spl id: 3e4c1179-51e9-6c04-e063-6294a90a89cd
spl set id: 0667ec26-c2cd-153c-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.