DR. SIMI STOMACH RELIEF- bismuth subsalicylate 525 mg suspension

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts Active ingredient (in each 30 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

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

Do not use if you have

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

Ask a doctor before use if you have

▪ fever ▪ mucus in stool

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

▪ anticoagulation (thinning of the blood)

▪ diabetes ▪ gout ▪ arthritis

When using this product

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

Stop use and ask a doctor if

▪ 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,

ask health professional before use.

Keep out of reach of children.

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

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

Immediate container labeling

INGREDIENTS AND APPEARANCE

DR. SIMI STOMACH RELIEF 
bismuth subsalicylate 525 mg suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-802
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 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-802-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	03/24/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma, Inc.		790523323	manufacture(85786-802)