MEDIQUE DIOTAME- bismuth subsalicylate suspension

MEDIQUE DIOTAME by

Drug Labeling and Warnings

MEDIQUE DIOTAME by is a Otc medication manufactured, distributed, or labeled by Unique First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Bismuth Salicylate 262 mg/15 ml

Purpose

Upset Stomach reliever / antidiarrheal

INDICATIONS & USAGE

Uses

Temporarily relieves

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

WARNINGS

Warnings

ADVERSE REACTIONS

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

Do not use if you have

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

ASK DOCTOR

Ask a doctor before use if you have

• fever
• mucus in the stool

ASK DOCTOR/PHARMACIST

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

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

WHEN USING

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

MEDIQUE DIOTAME 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-165
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-165-71	20 in 1 BOX	04/05/2011
1		30 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/05/2011

Labeler - Unique First Aid Corporation (832947092)

Registrant - Unique First Aid Corporation (832947092)