STOMACH RELIEF

Manufacturer
Consumer Value Products, Inc. | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:59

Label at a glance#

ProductSTOMACH RELIEF
Active ingredientBISMUTH SUBSALICYLATE
Label structure18 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate    525 mg

OTC - PURPOSE SECTION

Purposes
Bismuth subsalicylate .............. 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.

SPL UNCLASSIFIED SECTION

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

Slop 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
contains: sodium 13 mg, salicylate 256 mg
■ protect from freezing
■ avoid excessive heat (over 104ºF or 40ºC)
■ 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, xantham gum

OTC - QUESTIONS SECTION

Questions? 1-877-798-5944

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVP®

HEALTH

*COMPARE TO
PEPTO-BISMOL®
ACTIVE INGREDIENT

Stomach
Relief

PROTECTIVE COATING ACTION
Bismuth Subsalicylate

SOOTHING RELIEF FOR:

UPSET STOMACH
HEARTBURN
INDIGESTON
NAUSEA
COMMON DIARRHEA

8 FL OZ (237 mL)

TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken

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

DISTRIBUTED BY                                                         Made in USA
CONSUMER VALUE PRODUCTS, INC.                    LR-102 REV01
P.O. BOX 6115 TEMPLE, TX 76502

CVPproducts.com

7 61706 16202 6                                                 PEEL

                                                                          HERE

CVP 557-26 8OZ.jpgCVP 557-26 8OZ.jpg

                                        Stomach Relief by Consumer Value Products, Inc.

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
57243-557-26STOMACH RELIEF237 mL in 1 BOTTLESUSPENSION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-557STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CONSUMER VALUE PRODUCTS, INC.]2Current NDC, Legacy NDC, 1 package rows20231230_7526a3f2-ce7c-46c8-8ddf-1bcaf313876d.zip

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
57243-55757243-557-26

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
STOMACH RELIEFBISMUTH SUBSALICYLATEConsumer Value Products, Inc.7526a3f2-ce7c-46c8-8ddf-1bcaf313876d2023-12-29WarningsExact identifier
ndc (package): 57243-557-26
ndc (product): 57243-557
ndc11 (package): 57243055726
spl id: a16ba06a-8dfa-4da4-9639-7393b027d767
spl set id: 7526a3f2-ce7c-46c8-8ddf-1bcaf313876d

Reported adverse events (FAERS/openFDA)#

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