MEDIQUE DIOTAME- bismuth subsalicylate tablet, chewable 
Unifirst First Aid Corporation

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.

----------

Medique Diotame

Drug Facts

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Purpose

antidiarrheal/antacid

Uses

relieves

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:

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).

Directions

Adults and children: (12 years and over)

​Children under 12 years:

ask a doctor

Other information

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 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

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)

Revised: 5/2022
Document Id: de59b6e2-9822-6895-e053-2995a90afe06
Set id: 0667ec26-c2cd-153c-e054-00144ff88e88
Version: 14
Effective Time: 20220506
 
Unifirst First Aid Corporation