Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Bismuth subsalicylate 262 mg
Meijer Bismuth Stomach Relief Tablet, Chewable
FDA Label NDC 79481-0097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer for the product Meijer Bismuth Stomach Relief (NDC 79481-0097). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Upset stomach reliever and 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 salicylates products
Otc - Do Not Use
Do not use if you have
- An ulcer
- A bleeding problem
- Bloody or black stool
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 before use if you are taking any drug for
- Anticoagulation (thinning the blood)
- Diabetes
- Gout
- Arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Otc - Stop Use
Stop use and ask a doctor if
- Symptoms get worse or last 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Fully chew before swallowing
- Adults and children 12 years abd over:
- 2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed for diarrhea.
- 2 chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigenstion, nausea).
- Do not exceed 8 doses (16 chewable tablets) in 24 hours.
- Use until diarrhea stops but not more than 2 days
- Children under 12 years: ask a doctor.
- Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
Inactive Ingredient
Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.
Other Safety Information
Other information
- Each chewable tablet contains: Calcium 50mg
- Salicylate 123 mg
- Contains soy
- Store between 20° to 25°C (68° to 77°F) in a dry place. Avoid excessive heat (over40°C).
Otc - Questions
Questions? Call 1-800-245-2898 Mon - Fri, 9AM - 4PM EST
* Please review the disclaimer below.
