Label: STOMACH RELIEF ULTRA- bismuth subsalicylate liquid
- NDC Code(s): 55319-737-08
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 25, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 15 mL)
- Purpose
- Uses
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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
Ask a doctor or pharmacist before use if you are
taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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Directions
- do not take more than 8 doses (120 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- mL = milliliter
- shake well before using
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over:
- 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
- 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL® ULTRA*
Stomach Relief Ultra
Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal
RELIEVES 5 Major Symptoms
Heartburn
Indigestion
Upset Stomach
Diarrhea
Nausea
2x Strength Per Ounce†
Alcohol Free
Sugar Free
FL OZ (mL)
†This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320
- Package Label
-
INGREDIENTS AND APPEARANCE
STOMACH RELIEF ULTRA
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-737 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg in 15 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-737-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2019 10/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 10/30/2019 10/30/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)