Bismuth Subsalicylate Suspension Regular Strength - AptaPharma Inc.
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2026-06-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-04 05:10:12
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 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 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: Stomach Relief, Regular Strength
------------------------------------
AP SAFE® NDC 76281-557-28
*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
12FL 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™.
Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 081
LOT. EXP.
res
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0376281557282 | GTIN-13: 0376281557282 EAN-13: 0376281557282 GTIN-12: 376281557282 UPC-A: 376281557282 GTIN storage (14 digits): 00376281557282 | 76281-557 Botl.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
Products#
Every source-derived product name is available through these pages.
- Bismuth Subsalicylate Suspension Regular 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 |
|---|---|
| 76281-557 | 76281-557-28 |
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 |
|---|---|---|---|---|---|---|
| Bismuth Subsalicylate Suspension Regular Strength | BISMUTH SUBSALICYLATE | AptaPharma Inc. | f0976d6c-d574-49e8-b98a-23a660d83fa0 | 2026-06-02 | Warnings | 76281-557-28 76281-557 76281055728 ede65c2c-4034-46e5-9088-9efa801d6ec1 f0976d6c-d574-49e8-b98a-23a660d83fa0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
