FDA Label for Equate Bismuth Stomach Relief Chew
View Indications, Usage & Precautions
- 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
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Equate Bismuth Stomach Relief Chew Product Label
The following document was submitted to the FDA by the labeler of this product Walmart. 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.
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Bismuth subsalicylate 262 mg
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.
Otc - Do Not Use
Allergy alert: Contains salicylate. Do not take if you are
- Allergic to salicylates (including aspirin)
- taking other salicylate products
- An ulcer
- A bleeding problem
- Bloody or black stool
Do not use if you have
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 and 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, indigestion, 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, glycerin, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.
Other Safety Information
Other information
- Each chewable tablet contains: Calcium 50mg
- Salicylate 123mg
- Low sodium
- Store at no greater than 25°C (77°F). Avoid excessive heat (over 40°C).
Otc - Questions
Questions? Call 1-888-287-1915 Monday - Friday, 9AM to 4PM EST
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