Label: ULTRA BISMUTH- bismuth subsalicylate liquid
- NDC Code(s): 55910-637-04, 55910-637-12
- Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 19, 2024
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- 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)
-
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 of Pepto-Bismol® Ultra*
Ultra
Stomach Relief
Bismuth Subsalicylate 525 mg per 15 mL
Upset stomach reliever / antidiarrheal
Relieves
- Heartburn
- Upset stomach
- Nausea
- Indigestion
- Diarrhea
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 OLD EAST CO.
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072 USA
- Package Label
-
INGREDIENTS AND APPEARANCE
ULTRA BISMUTH
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-637 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:55910-637-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2019 2 NDC:55910-637-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 11/29/2019 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
