Active Ingredients And Purpose
Drug Facts Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 mg
Dr. Simi Stomach Relief
- Manufacturer
- Farmacias De Similares TX LLC | AptaPharma, Inc.
- Effective date
- 2026-03-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:45
Key Label Information#
Uses
Uses
relieves: ▪ diarrhea ▪ heart burn ▪ indigestion ▪ nausea ▪ upset stomach associated with these symptoms
Warnings
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
Directions And Dosage
Directions
▪ shake well before use ▪ use dose cup or tablespoon (TBSP) ▪ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed ▪ do not exceed 8 doses (240 mL or 16 TBSP) 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 Label Information
Inactive ingredients
benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum
Questions or comments?
(855)-280-1079
Principal Display Panel
NDC 85786-802-12 DR. SIMI Regular Strength Stomach Relief Bismuth Subsalicylate 525 mg Antidiarrheal /Upset Stomach Reliever Relieves: ▪ Upset Stomach ▪ Nausea ▪ Heartburn ▪ Indigestion ▪ Diarrhea 12 fl oz (354 mL) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken *Compare to the active ingredient in PEPTO-BISMOL™ *This product is not manufactured or distributed by Procter&Gamble the distributor of Pepto-Bismol ® Distributed by: FARMACIAS DE SIMILARES TX LLC. 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com
Immediate container labeling
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308762 | bismuth subsalicylate 525 MG in 30 mL Oral Suspension | PSN | 1 |
| 308762 | bismuth subsalicylate 17.5 MG/ML Oral Suspension | SCD | 1 |
| 308762 | bismuth subsalicylate 1.75 % Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 262 MG per 15 ML Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 524 MG per 30 ML Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 525 MG per 30 ML Oral Suspension | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85786-802-12 | Dr. Simi Stomach Relief | 354 mL in 1 BOTTLE | SUSPENSION | 354 | 1 |
Products#
- Dr. Simi Stomach Relief
- BISMUTH SUBSALICYLATE 525 MG
- BISMUTH CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-802 | 85786-802-12 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM ANHYDROUS | I4807BK602 | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
Complete SPL Sections#
Drug Facts Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 mg
Uses
relieves: ▪ diarrhea ▪ heart burn ▪ indigestion ▪ nausea ▪ upset stomach associated with these symptoms
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
Directions
▪ shake well before use ▪ use dose cup or tablespoon (TBSP) ▪ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed ▪ do not exceed 8 doses (240 mL or 16 TBSP) 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 cup contains: sodium 13 mg, salicylate 256 mg ▪ protect from freezing avoid excessive heat (over 104°F or 40C) ▪ low sodium
Inactive ingredients
benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum
Questions or comments?
(855)-280-1079
Principal Display Panel
NDC 85786-802-12 DR. SIMI Regular Strength Stomach Relief Bismuth Subsalicylate 525 mg Antidiarrheal /Upset Stomach Reliever Relieves: ▪ Upset Stomach ▪ Nausea ▪ Heartburn ▪ Indigestion ▪ Diarrhea 12 fl oz (354 mL) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken *Compare to the active ingredient in PEPTO-BISMOL™ *This product is not manufactured or distributed by Procter&Gamble the distributor of Pepto-Bismol ® Distributed by: FARMACIAS DE SIMILARES TX LLC. 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com