Indications and uses
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
adults and children 12 years and over • take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age
• each tablet contains: calcium 20 mg • store at 20°-25°C (68°-77°F) • do not use if blister unit is broken or torn
Pseudoephedrine HCl 30 mg
Nasal decongestant
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
do not exceed recommended dosage
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
adults and children 12 years and over |
|
children ages 6 to 11 years |
|
children under 6 years | do not use this product in children under 6 years of age |
carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide
1-800-719-9260
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24385-432-62 | EA - Each | 24385-432 | f182a63d-200a-47a0-b14c-2041cafa66f5 | 1 | 2012-07-24 |
| 24385-432-80 | EA - Each | 24385-432 | 99a71207-dfa0-4a08-9df6-fc9978f8208a | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24385-432 | 24385-432-62, 24385-432-80 |
Every source-derived ingredient row is available through these pages.
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 STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAVENOUS | 4680 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAMUSCULAR | 5 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, EXTENDED RELEASE / ORAL | 360 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | OINTMENT / TOPICAL | 0.1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 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 |
|---|---|---|---|---|---|---|
| c344c9b3-d447-438e-b2ef-8ee3db831235 | 090ebc50-d8ba-4b7b-93af-471679edeb98 | 2024-10-16 | Warnings | c344c9b3-d447-438e-b2ef-8ee3db831235 090ebc50-d8ba-4b7b-93af-471679edeb98 |
Adverse event summaries are temporarily unavailable. Other product information remains available.