MEDIQUE DIOTAME- bismuth subsalicylate tablet, chewable

Medique Diotame by

Drug Labeling and Warnings

Medique Diotame by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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

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

Directions

• do not use more than directed
• chew or crush tablets completely before swallowing
• do not swallow tablets whole
• 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 in 24 hours

Adults and children: (12 years and older)

Take 2 tablets every 1/2 to 1 hour or 4 tablets 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

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

QUESTIONS

Questions or comments? 1-800-634-7680

Medique Diotame Label

Medique®

Diotame

Chewable Tablets

Chew or crush tablets completely before swallowing

Do not swallow tablets whole

Pull To Open

Upset Stomach/Diarrhea Bismuth Subsalicylate 262 mg

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDIQUE DIOTAME 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-210
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

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	RH;046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-210-83	15 in 1 BOX	04/01/2014
1	NDC: 47682-210-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-210-33	50 in 1 BOX	04/01/2014
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-210-13	250 in 1 BOX	04/01/2014
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-210-64	12 in 1 BOX	04/01/2014
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 47682-210-99	2 in 1 PACKET; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/01/2014

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-210) , repack(47682-210)