Bismuth Subsalicylate Suspension Regular Strength

Manufacturer
FSA Store Inc. (Caring Mill)
Effective date
2025-09-18
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:21

Label at a glance#

ProductBismuth Subsalicylate Suspension Regular Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 525 mg

PURPOSES

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

INDICATIONS & USAGE SECTION

Uses relieves • travelers' diarrhea • diarrhea
• upset stomach due to overindulgence of food and drink
including: • heart burn • indigestion • nausea • gas
• belching

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have   • an ulcer

• a bleeding problem        • black or bloody stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• fever • mucus in stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
taking any drug for • anticoagulation (thinning of the blood)
• diabetes • gout • arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information
• each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg
• protect from freezing • avoid excessive heat (over 104°F or 40°C)
• low sodium

INACTIVE INGREDIENT SECTION

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

===============================

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

caring mill™ Stomach Relief Labeling

NDC 81522-557-28

caring mill™

Stomach 

Relief

Compare to the active ingredients in Pepto-Bismol​™

Regular Strength

Bismuth Subsalicylate

Antidiarrheal / Upset Stomach Reliever

12 FL OZ 
(354 mL)

"This product is not manufactured or distributed by
Procter & Gamble, Inc., the distributor of
Pepto-Bismol​™​.

Made in USA     LR-224
Manufactured for FSA Store Inc.
5473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231

Bismuth 354 mLBismuth 354 mL

res

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-557-28Bismuth Subsalicylate Suspension Regular Strength354 mL in 1 BOTTLELIQUID3541

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81522-55781522-557-28

Ingredients#

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

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

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
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
ndc (package): 81522-557-28
ndc (product): 81522-557
ndc11 (package): 81522055728
spl id: 85cccecc-9d78-43fe-86cc-9eea9027d4ba
spl set id: fbabc313-600a-4722-9948-1a3e21414059

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.