FDA Label for Medique Diotame
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY DRUG FOR
- STOP USE AND ASK A DOCTOR IF
- OTC - WHEN USING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- DIRECTIONS
- ADULTS AND CHILDREN: (12 YEARS AND OLDER)
- CHILDREN UNDER 12 YEARS:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- 220R MEDIQUE DIOTAME LABEL
Medique Diotame Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
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
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
Otc - 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.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.
Otc - Pregnancy Or Breast Feeding
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 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
Otc - Questions
Questions or comments? 1-800-634-7680
220R Medique Diotame Label
Medique®
Diotame
Chewable Tablets
Pull To Open
Upset Stomach/Diarrhea • Bismuth Subsalicylate 262 mg
100 Tablets
(50 x 2)
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.