Right Remedies Stomach Relief Bismuth Subsalicylate 262 Mg Softgel Capsule, Liquid Filled
FDA Label NDC 70692-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Right Remedies Stomach Relief Bismuth Subsalicylate 262 Mg Softgel (NDC 70692-829). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Bismuth subsalicylate 262 mg
Purpose
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 or last more than 2 days
• 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Directions
• swallow with water, do not chew
• adults and children 12 years and over:
• 2 softgels every 1/2 hour or 4 softgels every hour as needed for diarrhea
• 2 softgels every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 16 softgels in 24 hours
• use until diarrhea stops but no 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 softgel contains: salicylate 102 mg
• store at controlled room temperature 20–25°C (68–77°F)
• protect from light, heat and moisture
Inactive Ingredients
beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxy methyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide
Questions Or Comments?
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Packaging
Rr Stomach Relief (70692829 3)
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