Indications and uses
relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
shake well before use mL=milliliter measure only with dosing cup provided. Do not use any other dosing device adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed 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 informati...
Active ingredient (in each 30 mL dose cup)
Bismuth subsalicylate 525 mg
Upset stomach reliever and antidiarrheal
relieves
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 use if you have
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other information
benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate type 1C, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum
Questions or comments?
1-855-274-4122
* This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-BismolTM.
Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648
NDC 58602-516-26
Primary Health
COMPARE TO Pepto-BismolTM
active ingredient*
Stomach Relief
Bismuth Subsalicylate Liquid
Upset Stomach Reliever/
Antidiarrheal
Each 30 mL dose of oral solution contains:
525 mg - Bismuth subsalicylate
5 Symptom Digestive Relief
Original Flavor
16 FL OZ (473 mL)
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-516 | 58602-516-26 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| MAGNESIUM ALUMINUM SILICATE TYPE IC | XLI9KNX1FT | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 361f10b7-f81d-43fd-9197-bfb7f0f52c2e | fb40c8eb-c4ca-4d65-93b0-7b7ff5ef3c4f | 2020-11-27 | Warnings | 361f10b7-f81d-43fd-9197-bfb7f0f52c2e fb40c8eb-c4ca-4d65-93b0-7b7ff5ef3c4f |
Adverse event summaries are temporarily unavailable. Other product information remains available.