Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled
- NDC Code(s): 83059-0026-8
- Packager: Shield Pharmaceuticals Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 7, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Uses
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
• swallow with water, do not chew
• adults and children 12 years and over:
• 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
• 2 softgels every ½ hour to 1 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
- Questions or comments?
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STOMACH RELIEF
bismuth subsalicylate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83059-0026 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH 262 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code SD30 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83059-0026-8 1 in 1 CARTON 04/07/2024 1 8 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 04/07/2024 Labeler - Shield Pharmaceuticals Corp (118724924)