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#

ProductBismuth Subsalicylate Suspension 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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

------------------------------------

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.

76281-557 Botl76281-557 Botl

res

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376281557282GTIN-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 table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

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
76281-55776281-557-28

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
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
ndc (package): 76281-557-28
ndc (product): 76281-557
ndc11 (package): 76281055728
spl id: ede65c2c-4034-46e5-9088-9efa801d6ec1
spl set id: f0976d6c-d574-49e8-b98a-23a660d83fa0

Reported adverse events (FAERS/openFDA)#

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