Stomach Relief
FDA Label NDC 68210-4238
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Stomach Relief (NDC 68210-4238). 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 tablet), purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and anti-diarrheal
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 If You Are
you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis
When Using This Product
• 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.
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
• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) 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 softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)
Inactive Ingredients
Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide
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