CVS Health Non-Drowsy Nasal Decongestant
- Manufacturer
- Westport Pharmaceuticals | Patheon Manufacturing Services LLC | Patheon Manufacturing Services
- Effective date
- 2015-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:43:47
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each pill)
Pseudoephedrine HCl 30 mg
OTC - PURPOSE SECTION
Purpose
Nasal Decongestant
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. (1-800-222-1222)
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
WARNINGS SECTION
Warnings
Do not use 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.
Ask a doctor before use if you have
• heart disease • high blood pressure • thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland
When using this product do not exceed recommended dose
Stop and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
If pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions: remove pill from sealed, plastic packaging before ingesting
swallow whole – do not crush, chew or dissolve
adults and children 12 years and over • take 2 pills every 4 to 6 hours
• do not take more than 8 pills in 24 hours
children ages 6 to under 12 years • take 1 pill every 4 to 6 hours
• do not take more than 4 pills in 24 hours
children ages under 6 years do not use this product in children
under 6 years of age
INACTIVE INGREDIENT SECTION
Inactive Ingredients croscarmellose sodium, guar gum, hydroxypropyl cellulose, lecithin,
microcrystalline cellulose, polyethylene glycol, sorbitan monooleate, vegetable oil, xanthan gum
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0050426521900 | GTIN-13: 0050426521900 EAN-13: 0050426521900 GTIN-12: 050426521900 UPC-A: 050426521900 GTIN storage (14 digits): 00050426521900 | CVS Nasal Decongestant 96 Count Carton SM.jpg |
| Data code | Code 128 | 014784 | CVS Nasal Decongestant 96 Count Carton SM.jpg |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53240-280-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2281-f424-e053-dadaa90a57ce | 085a57b6-75f5-4ecc-b831-11383f5f68a7 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53240-280-01 | CVS Health Non-Drowsy Nasal Decongestant | 96 in 1 PACKAGE | PILL | 96 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 3 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 3 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | 3 | |
| HYDROGENATED PALM KERNEL OIL | INACTIVE INGREDIENT | FM8D1RE2VP | 3 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 3 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 3 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Products#
Every source-derived product name is available through these pages.
- CVS Health Non-Drowsy Nasal Decongestant
- Pseudoephedrine Hydrochloride
- PSEUDOEPHEDRINE
- CROSCARMELLOSE SODIUM
- GUAR GUM
- HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
- LECITHIN, SOYBEAN
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL 3350
- SORBITAN
- HYDROGENATED PALM KERNEL OIL
- XANTHAN GUM
- FD&C RED NO. 40
- GELATIN
- POLYSORBATE 80
- WATER
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53240-280 | 53240-280-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE | 2165RE0K14 | TABLET / ORAL | 480 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| GUAR GUM | GUAR GUM | E89I1637KE | CAPSULE / ORAL | 3.3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET, EXTENDED RELEASE / ORAL | 24 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRA-ARTICULAR | 56 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVITREAL | 0.02 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRALESIONAL | 4 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, DELAYED RELEASE / ORAL | 10 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / VAGINAL | 28 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, CHEWABLE / ORAL | 15 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / OPHTHALMIC | 0.05 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAMUSCULAR | 5 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | OINTMENT / TOPICAL | 0.1 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE | 2165RE0K14 | TABLET, DELAYED RELEASE / ORAL | 103 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg |
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 |
|---|---|---|---|---|---|---|
| 1ee84888-9ec5-42e4-81d2-fe1c0cf4c4f9 | 085a57b6-75f5-4ecc-b831-11383f5f68a7 | 2015-10-07 | Warnings | 1ee84888-9ec5-42e4-81d2-fe1c0cf4c4f9 085a57b6-75f5-4ecc-b831-11383f5f68a7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
