STOMACH RELIEF
- Manufacturer
- Pharmacy Value Alliance, LLC | AptaPharma Inc.
- Effective date
- 2019-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:50:51
Label at a glance#
Contacts and useful links#
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 1050 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 before use
• use dose cup or tablespoon (TBSP)
• adulls and children 12 years and over: 1dose
(30 mL or 2 TBSP) every I hour as needed
• do not exceed 4 doses (120 mL or 8 TBSP) in 24 hours
• use until diarrhea stops bul 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, salicylale 455 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
OTC - QUESTIONS SECTION
Ouestions? 1-877-798-5944.
Principal Display Panel
Premier
Value®
COMPARE TO THE ACTIVE
INGREDIENTS IN
PEPTO BISMOLTM
MAXIMUM STRENGTH*
STOMACH
RELIEF
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
Maximum Strength
5 Symptom Relief of:
• Nausea • Heartburn • Indigestion
• Diarrhea • Upset stomach
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-120
407 East Lancaster Avenue,
Wayne, PA 19087
8 40986 03583 8
→DRUG fACTS CONTINUED ON BACK →
res
Products#
Every source-derived product name is available through these pages.
- STOMACH RELIEF Maximum Strength
- BISMUTH SUBSALICYLATE
- SALICYLIC ACID
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- WATER
- SACCHARIN SODIUM
- SODIUM SALICYLATE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-558 | 68016-558-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ad4fe69f-0211-4471-956a-a813d3f72e5a | 537eeea2-d616-4e6d-8e11-f61f0537adfc | 2023-12-30 | Warnings | 537eeea2-d616-4e6d-8e11-f61f0537adfc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
