FDA Label for Peptic Relief
View Indications, Usage & Precautions
Peptic Relief Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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
Bismuth Subsalicytate 262mg
Purpose
Anti-diarrheal/Upset stomach reliever
Keep Out Of Reach Of Children
In case of overdose,, get medical help or contact a Poison Control Center right away.
Uses
* Relieves: diarrhea, hearbrun, indigesttion, nausea, upset stomach associated with these symptoms
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: Do not take if you are
* allergic to salicylates (including aspirin)
* taking other salicylate products
Do not use
* if you have bloody or black stool
* if you have an ulcer or bleeding problem
Ask a doctor before use if you have
* fever
* mucus in the stool
Drug Facts
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.
Directions
* drink plenty of clear fluids to help prevent dehydration caused by diarrhea
* repeat dosage every 1/2 to 1 hour as needed
* do not take more than 8 doses (16 tablets) in 24 hours
* use until diarrhea stops but not more than 2 days
* adults and children 12 years and over:
2 tablets every 1/2 to 1 hour as needed
* children under 12 years: ask a doctor
Other Information
* each tablet contains: calcium 140 mg
salicylate 102mg
sodium less than 1 mg (very low sodium)
* store at 15°-30°C (59°-86°F); avoid excessive heat (over 104°F or 40°C)
* protect from moisture
Inactive Ingredients
calcium carbonate, D&C red #27 (aluminum lake), flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium
Questions Or Comments?
call 1-800-645-2158
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