FDA Label for Stomach Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Stomach Relief Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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.
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Purposes
Upset stomach reliever and antidiarrheal
Uses
relieves
• travelers’ diarrhea• diarrhea• upset stomach 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
• an ulcer• a bleeding problem• bloody or black stool
Ask A Doctor Before Use If You Have
• fever• mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
taking any drug for
• anticoagulation (thinning the blood)• diabetes• gout• arthritis
When Using This Product
a temporary, but harmless, darkening of the stool and/or tongue may occur
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• chew or dissolve in mouth• adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed• do not exceed 8 doses (16 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
Other Information
• each tablet contains: calcium 190 mg• salicylate 104 mg• very low sodium• store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
Inactive Ingredients
calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium, stearic acid
Questions Or Comments?
1-800-719-9260
Principal Display Panel
GREAT SIZE FOR TRAVEL
CHEWABLE
stomach relief
Upset Stomach Reliever | Anti-diarrheal
Bismuth Subsalicylate 262 mg
5 SYMPTOM RELIEF OF: Heartburn | Indigestion | Nausea | Upset Stomach | Diarrhea
Compare to Pepto-Bismol® active ingredient
6 Tablets | actual size
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