FDA Label for Thompson Chewable Bismuth Tabs
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Thompson Chewable Bismuth Tabs Product Label
The following document was submitted to the FDA by the labeler of this product Thompson Safety Llc. 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
Otc - Active Ingredient
Active ingredient
Bismuth Subsalicylate 262 mg
(each tablet contains 102 mg salicylate)
Otc - Purpose
Purpose
Upset stomach reliever/antidiarrheal
Indications & Usage
Uses
relieves
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including: • heartburn, • indigestion, • nausea, • gas, • belching, • fullness
Warnings
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
Otc - Do Not Use
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product a temporary and harmless darkening of the tongue and/or stool may occur.
Otc - Stop Use
Stop use and ask a doctor if
- symptoms get worse or lasts more than 2 days
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222)
Dosage & Administration
Directions
- chew or dissolve in mouth
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- chew 2 tablets every 1/2 to 1 hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
Adults and children: (12 years and over)
Children under 12 years: ask a doctor
Other Safety Information
Other information
- phenylketonurics: contains phenylalanine 1.1mg per tablet
- calcium content per tablet: 73mg
- store at room temperature 59°-86°F (15°-30°C)
- tamper-evident sealed packets
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Otc - Questions
Questions or comments? 877.506.4291
Package Label.Principal Display Panel
Chewable Bismuth Tabs
Upset Stomach / Diarrhea Relief
Thompson
Safety Works | Business Thrives™
Bismuth Subsalicylate 262 MG
36 Tablets
Tamper Evident
* Please review the disclaimer below.