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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.Ronkonkoma, NY 11779
Stomach Relief
FDA Label NDC 83059-0126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Stomach Relief (NDC 83059-0126). 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 other, active ingredient (in each 30 ml dose), purpose, uses, reye's syndrome:, allergy alert: contains salicylate. do not take if you are, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 30 Ml Dose)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever and antidiarrheal
Uses
relieves
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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
Otc - Do Not Use
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
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 (1-800-222-1222).
Directions
- shake well before use
- only use dose cup provided
- adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) 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 30 mL dose contains:magnesium 3 mg, sodium 4 mg
- salicylate 261 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
TAMPER EVIDENT:Do not use if printed shrinkband is missing or broken.
Inactive Ingredients
FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, purified water, sorbitan, sorbitol solution, titanium dioxide
Questions?
1-800-373-6981
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