Active Ingredient
Bismuth Subsalicytate 262mg
Peptic Relief
FDA Label NDC 21695-639
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Peptic Relief (NDC 21695-639). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, drug facts, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Controls diarrhea
* Relieves upset stomach due to overindulgence in food or drink
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 in 24 hours
* use until diarrhea stops but not more than 2 days
* adults and children 12 years and over:
2 tablets
* children under 12 years: ask a doctor
Other Information
* each tablet contains: calcium 77mg
salicylate 102mg
* store at 15°-30°C (59°-86°F)
* protect from moisture
Inactive Ingredients
D&C red #27 (al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol
Questions Or Comments?
call 1-800-645-2158, 9 am-5 pm EST, Monday-Friday.
Package/Label Principal Display Panel
Peptic Relief 262mg (39fd1b7e Fac0 4d6f 8bc2 4af6e880a53d 01)
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