STOMACH RELIEF

Manufacturer
Pharmacy Value Alliance, LLC | AptaPharma Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:24

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
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
recovenng 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.

OTHER SAFETY INFORMATION

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 a 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 belore 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 104ο F or 40ο 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

OTC - QUESTIONS SECTION

Ouestions?  1-877-798-5944.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier

Value®

COMPARE TO THE ACTIVE
INGREDIENTS IN
PEPTO BISMOLTM*

STOMACH
RELIEF

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

Regular Strength

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

8 FL OZ (237 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

TAMPER EVIDENT: Do not use if imprinted

shrinkband is missing or broken

*This product is not manufactured or distnbuted by Procter & Gamble,
Inc., the distributor of Pepto-BismolTM.

Distributed By:                                                            Made in USA
Pharmacy Value Alliance, LLC                                              LR-121
407 East Lancaster Avenue,
Wayne, PA 19087

8 40986 03581 4

→DRUG fACTS CONTINUED ON BACK →

8 fl oz pkg.

pva 557-08pva 557-08

12 fl oz pkg.

pva 557-12pva 557-12

res

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-55768016-557-08, 68016-557-12

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
0f07899c-0512-4ba3-9c8b-e22f5d8c934dda267288-b9df-4e5e-8739-9e6b9dc6a5342024-12-29WarningsExact identifier
spl set id: da267288-b9df-4e5e-8739-9e6b9dc6a534

Reported adverse events (FAERS/openFDA)#

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