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MEDIQUE DIOTAME by Unique First Aid Corporation

Medically reviewed on June 11, 2018

Dosage form: suspension
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: Unique First Aid Corporation
NDC Code: 47682-165

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 Facts

Bismuth Salicylate 262 mg/15 ml

Upset Stomach reliever / antidiarrheal

Uses

Temporarily relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach 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

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

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. Stool darkening should not be confused with melena.

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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before use
  • Drink plenty of clear fluids to help prevent dehydrationcaused by diarrhea

Adults and children: (12 years and over)- Take 1 dose (2 tablespoons or 30 ml) every 1/2 to 1 hour, as needed.

Do not exceed 8 doses (16 Tbs or 240 ml) in 24 hours. Use until diarrhea stops, but not more than 2 days.

Children under 12 years: Do not give to children under 12 years of age.

Other information

  • tamper evident, do not use if container is torn, cut or opened
  • store at controlled room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity

Inactive ingredients

benzoic acid, citric acid, D&C red #22, D&C red #28, hydroxypropyl methylcellulose, methyl salicylate, purified water, salicylic acid, sodium saccharin, sorbic acid, veegum

Questions or comments? 1-800-634-7680

158R Medique Diotame InstyDose Label

Medique®

Diotame

InstyDose®

Liquid Relief from Stomach Upset & Diarrhea

Liquido para aliviar el malestar estomacal y la diarrea

Bismuth Subsalicylate 262 mg per 15 ml

Subsalicilato de Bismuto 262 mg per 15 ml

20 – 30 ml

Liquid

Packets

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Untarias

MEDIQUE DIOTAME 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE 
WATER 
D&C RED NO. 22 
D&C RED NO. 28 
CITRIC ACID MONOHYDRATE 
SALICYLIC ACID 
SACCHARIN SODIUM 
SORBIC ACID 
BENZOIC ACID 
HYPROMELLOSES 
MAGNESIUM ALUMINUM SILICATE 
Packaging
#Item CodePackage Description
1NDC:47682-165-7120 PACKET in 1 BOX
130 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/05/2011
Labeler - Unique First Aid Corporation (832947092)
Registrant - Unique First Aid Corporation (832947092)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(47682-165)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(47682-165)

 
Unique First Aid Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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