FDA.reportPublic FDA data

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

Label at a glance#

ProductDr. Simi Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

relieves: ▪ diarrhea ▪ heart burn ▪ indigestion ▪ nausea ▪ upset stomach associated with these symptoms

Dosage and administration

▪ 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

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves: ▪ diarrhea ▪ heart burn ▪ indigestion
▪ nausea ▪ upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

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 if you have

OTC - DO NOT USE SECTION

▪ an ulcer
▪ a bleeding problem
▪ black or bloody stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

▪ fever ▪ mucus in stool

Ask a doctor or pharmacist before use if you are taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

▪ anticoagulation (thinning of the blood)

▪ diabetes ▪ gout ▪ arthritis

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ diarrhea lasts more than 2 days

▪ symptoms get worse or last more than 2 days

▪ ringing in the ears or loss of hearing occurs

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN1
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD1
308762bismuth subsalicylate 1.75 % Oral SuspensionSY1
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY1
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY1
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-802-12Dr. Simi Stomach Relief354 mL in 1 BOTTLESUSPENSION3541

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-80285786-802-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
XANTHAN GUMTTV12P4NEEIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
SALICYLIC ACIDO414PZ4LPZIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
SODIUM SALICYLATEWIQ1H85SYPIACT

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Stomach ReliefBISMUTH SUBSALICYLATE 525 MGFarmacias De Similares TX LLC4dc9233e-68fb-e1e8-e063-6294a90aee332026-03-24WarningsExact identifier
ndc (package): 85786-802-12
ndc (product): 85786-802
ndc11 (package): 85786080212
spl id: 4dc9233e-68fc-e1e8-e063-6294a90aee33
spl set id: 4dc9233e-68fb-e1e8-e063-6294a90aee33