MEDIQUE DIOTAME- bismuth subsalicylate suspension 
Unique 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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Medique Diotame Instydose

Active ingredient

Bismuth Salicylate 262 mg/15 ml

Purpose

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

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

Diotame

MEDIQUE DIOTAME 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-165
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  in 15 mL
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE (UNII: LAV5U5022Y)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-165-7120 in 1 BOX04/05/201103/31/2022
130 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/05/201103/31/2022
Labeler - Unique First Aid Corporation (832947092)
Registrant - Unique First Aid Corporation (832947092)

Revised: 1/2023
 
Unique First Aid Corporation