Indications and uses
upset stomach indigestion nausea heartburn diarrhea
Pepbis
- Manufacturer
- KC Pharmaceuticals, Inc.
- Effective date
- 2011-05-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:51:24
Label at a glance#
ProductPepbis Regular
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections
Dosage and administration
Shake well before use For convenience, use the dosage cup adults and children 12 yrs and over 2 Tbsp or 30 mL children 9 to under 12 years 1 Tbsp or 15 mL children 6 to under 9 years 2 tsp or 10 mL children 3 to under 6 years 1 tsp or 5 mL children under 3 years consult a doctor Repeat above dosage every 1/2 to 1 hour as needed to a maximum of 8 doses in a 24-hour period
Storage and handling
Do not use if imprinted safety seal around the dosage cup and bottle is broken or missing each tablespoon (15 mL) contains: sodium 1 mg each tablespoon (15 mL) contains: salicylate 130 mg sugar free low in sodium avoid excessive heat (over 104 o F or 40 o C) protect from freezing may cause a temporary and harmless darkening of the tongue or stool
Label contents#
Full prescribing information#
Active Ingredients
Bismuth subsalicylate, 262 mg
Purpose
Bismuth subsalicylate - Upset stomach reliever and Antidiarrheal
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
Uses
- upset stomach
- indigestion
- nausea
- heartburn
- diarrhea
Warnings
Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox, flu symptoms, or flu should NOT use this product. If nausea, vomiting or fever occur, consult a doctor because these symptoms could be an early sign of Reye Syndrom, a rare but serious illness.
Allergy Alert: do not take this product if you are allergic to salicylates (including aspirin) unless directed by a doctor.
Do not use for diarrhea on children under 3 years of age
Ask a doctor or a pharmacist before use if you are taking prescription medicines for anticoagulation (thinning of the blood), diabetes, gout or arthritis.
Stop use and ask a doctor if
- you are taking this product with other salicylate-containing preparations (such as aspirin) and ringing in the ears occurs. This product contains salicylate.
- diarrhea is accompanied by a high fever or continues for more than 2 days
- other symptoms last more than 2 weeks
Directions
- Shake well before use
- For convenience, use the dosage cup
| adults and children 12 yrs and over | 2 Tbsp or 30 mL |
| children 9 to under 12 years | 1 Tbsp or 15 mL |
| children 6 to under 9 years | 2 tsp or 10 mL |
| children 3 to under 6 years | 1 tsp or 5 mL |
| children under 3 years | consult a doctor |
- Repeat above dosage every 1/2 to 1 hour as needed to a maximum of 8 doses in a 24-hour period
Inactive Ingredients
FD and C Red No. 3, FD and C Red No. 40, flavor, magnesium aluminum silicate, methylcellulose, saccharin sodium, salicylic acid, sodium salicylate, and water
Other information
- Do not use if imprinted safety seal around the dosage cup and bottle is broken or missing
- each tablespoon (15 mL) contains: sodium 1 mg
- each tablespoon (15 mL) contains: salicylate 130 mg
- sugar free
- low in sodium
- avoid excessive heat (over 104oF or 40oC)
- protect from freezing
- may cause a temporary and harmless darkening of the tongue or stool
If pregnant or breast-feeding
ask a health professional before use.
Principal Display Panel
PBRG
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55651-264-01 | 2021-12-18 | C162847 | 48780-1 | 9d75b9d1-2472-f424-e053-dadaa90a57ce | Drug Facts |
| 55651-264-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2472-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BISMUTH SUBSALICYLATE | ACTIVE INGREDIENT | 62TEY51RR1 | 2 | |
| BISMUTH SUBSALICYLATE | ACTIVE MOIETY | 62TEY51RR1 | 2 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 2 | |
| METHYL SALICYLATE | INACTIVE INGREDIENT | LAV5U5022Y | 2 | |
| METHYLCELLULOSE (400 CPS) | INACTIVE INGREDIENT | O0GN6F9B2Y | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 2 | |
| SALICYLIC ACID | INACTIVE INGREDIENT | O414PZ4LPZ | 2 | |
| SODIUM SALICYLATE | INACTIVE INGREDIENT | WIQ1H85SYP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Pepbis Regular
- Bismuth subslicylate
- BISMUTH SUBSALICYLATE
- FD&C RED NO. 3
- FD&C RED NO. 40
- METHYL SALICYLATE
- MAGNESIUM ALUMINUM SILICATE
- METHYLCELLULOSE (400 CPS)
- SACCHARIN SODIUM
- SALICYLIC ACID
- SODIUM SALICYLATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55651-264 | 55651-264-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| FD&C RED NO. 3 | PN2ZH5LOQY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| METHYLCELLULOSE (400 CPS) | O0GN6F9B2Y | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CAPSULE / ORAL | 60 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | CAPSULE / ORAL | 16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / ORAL | 5000 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | GRANULE, FOR SUSPENSION / ORAL | 12.5 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, CHEWABLE / ORAL | 12 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | LOZENGE / ORAL | 53 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | PASTE, DENTIFRICE / DENTAL | 1.1 %w/w | ||
| METHYLCELLULOSE (400 CPS) | METHYLCELLULOSE (400 MPA.S) | O0GN6F9B2Y | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET / ORAL | 60 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CREAM / TOPICAL | 3 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | DOUCHE / VAGINAL | 0.05 %w/w | ||
| METHYLCELLULOSE (400 CPS) | METHYLCELLULOSE (400 MPA.S) | O0GN6F9B2Y | TABLET / ORAL | 33 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | OINTMENT / VAGINAL | 231 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER, DENTIFRICE / DENTAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | GEL / TOPICAL | 0.05 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION/ DROPS / ORAL | 4.15 mg/2.5ml |
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 |
|---|---|---|---|---|---|---|
| 985ed6a0-c098-4eba-e053-2995a90a9759 | 050b2c5b-622d-4e3c-b301-1b5346af11f4 | 2021-12-16 | Warnings | 050b2c5b-622d-4e3c-b301-1b5346af11f4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.