Stomach Relief - Regular Strength

Manufacturer
AptaPharma Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:07

Label at a glance#

ProductStomach Relief - Regular Strength
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 adoctor
■ 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 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

AP SAFE                                NDC 76281-537-28

*COMPARE TO
the active ingredient in
PEPTO-BISMOL™

Stomach
Relief
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

Regular Strength

5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea

12 FL OZ (354 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™.
Made in USA            AP-LR-11 REV01
Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

3 76281 53728 4

12 OZ

Stomache Relief Reg 12 OZStomache Relief Reg 12 OZ

6 OZ

537-25 6OZ537-25 6OZ

                                              Stomach Relief - Regular Strength by AptaPharma Inc.

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN5
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD5
308762bismuth subsalicylate 1.75 % Oral SuspensionSY5
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY5
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY5
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY5

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
76281-537-25Stomach Relief - Regular Strength177 mL in 1 BOTTLELIQUID1775
76281-537-28Stomach Relief - Regular Strength354 mL in 1 BOTTLELIQUID3545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-537STOMACH RELIEF - REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [APTAPHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20231231_970b4118-2c2e-4806-8fe8-937ba06cf6e9.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
76281-53776281-537-28, 76281-537-25

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 Relief - Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.970b4118-2c2e-4806-8fe8-937ba06cf6e92023-12-30WarningsExact identifier
ndc (package): 76281-537-25
ndc (package): 76281-537-28
ndc (product): 76281-537
ndc11 (package): 76281053728
ndc11 (package): 76281053725
spl id: 0e43e21f-d421-4a57-9056-85b2f73aadd8
spl set id: 970b4118-2c2e-4806-8fe8-937ba06cf6e9

Reported adverse events (FAERS/openFDA)#

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