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.

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220R Medique Diotame

Drug Facts

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal

Uses

Temporarily relieves

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

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

Stop use and ask a doctor if

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

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

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

Directions

  • do not use more than directed
  • chew or dissolve in mouth
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets (4,200mg) in 24 hours

Adults and children: (12 years and older)

Take 2 tablets (525mg) every 1/2 to 1 hour or 4 tablets (1,050mg) every hour as needed

Children under 12 years:

Do not give to children under 12 years of age.

Other information

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

Inactive ingredients

aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments? 1-800-634-7680

220R Medique Diotame Label

Medique ®

Diotame

Bismuth Subsalicylate

Indigestion •Upset Stomach •Heartburn

Diarrhea •Nausea

Pull To Open

Chewable Tablets

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

220R Medique Diotame Label
MEDIQUE DIOTAME 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-220
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) 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)  
Product Characteristics
Colorpink (pink) Scoreno score
ShapeROUND (ROUND) Size16mm
FlavorImprint Code RH;046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-220-6412 in 1 BOX, UNIT-DOSE
1NDC:47682-220-992 in 1 PACKET
2NDC:47682-220-8315 in 1 BOX, UNIT-DOSE
2NDC:47682-220-992 in 1 PACKET
3NDC:47682-220-3350 in 1 BOX, UNIT-DOSE
3NDC:47682-220-992 in 1 PACKET
4NDC:47682-220-13250 in 1 BOX, UNIT-DOSE
4NDC:47682-220-992 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/30/200807/22/2017
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 11/2014
Document Id: 07d585ce-389d-349a-e054-00144ff8d46c
Set id: 812bf7a4-0d90-4935-aaef-58b2f7e27059
Version: 3
Effective Time: 20141114
 
Unifirst First Aid Corporation