OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Bismuth subsalicylates 262mg...........Antidiarrheal/Antacid
Active Ingredient
Bismuth subsalicylates 262mg...........Antidiarrheal/Antacid
Uses
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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert
Contains salicylate. Do not take if you are
Do not use if you have
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking any drug for
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Adults and Children 12 years and over: 525mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hours as needed. Do not exceed 4200mg (16 tablets) in 24 hours. Use until diarrhea stops but not more than 2 days. Children under 12 years ask a doctor
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and Children 12 years and over: 525mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hours as needed. Do not exceed 4200mg (16 tablets) in 24 hours. Use until diarrhea stops but not more than 2 days. Children under 12 years ask a doctor
Other information:
aspatame, calcium carbonate, D and C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-0235-16 | EA - Each | 0603-0235 | 8eebcaa9-4ff0-4c7d-964a-cf4a3bae724f | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BISMUTH SUBSALICYLATE | ACTIVE INGREDIENT | 62TEY51RR1 | 8 | |
| BISMUTH SUBSALICYLATE | ACTIVE MOIETY | 62TEY51RR1 | 8 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 8 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 8 | |
| DEXTRATES | INACTIVE INGREDIENT | G263MI44RU | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68788-0190 | 68788-0190-3 |
| 0603-0235 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| DEXTRATES | G263MI44RU | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER / ORAL | 63 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | FILM, SOLUBLE / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, DELAYED RELEASE / ORAL | 8.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, DELAYED RELEASE / ORAL | 20 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / ORAL | 87 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| DEXTRATES | DEXTRATES | G263MI44RU | TROCHE / ORAL | 4505 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / RESPIRATORY (INHALATION) | 4.02 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| DEXTRATES | DEXTRATES | G263MI44RU | TABLET, CHEWABLE / ORAL | 6398 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, EXTENDED RELEASE / ORAL | 229.7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / SUBLINGUAL | 8 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| DEXTRATES | DEXTRATES | G263MI44RU | TABLET, ORALLY DISINTEGRATING / ORAL | 311 mg |
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 |
|---|---|---|---|---|---|---|
| 80d920c4-0757-439e-b0c2-cbbe81109f77 | c069d188-5a79-4885-835b-afb69eaf8a48 | 2019-11-11 | Warnings | c069d188-5a79-4885-835b-afb69eaf8a48 |
Adverse event summaries are temporarily unavailable. Other product information remains available.