CVS Health Non-Drowsy Nasal Decongestant
- Manufacturer
- Westport Pharmaceuticals | Patheon Pharmaceutical Services | Patheon Manufacturing Services LLC
- Effective date
- 2015-10-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- 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 |
|---|---|---|---|---|
| Data code | Code 128 | 014783 | CVS Nasal Decongestant 48 Count Carton SM.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53240-240-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f6ef-f424-e053-dadaa90a57ce | c4104df9-2f42-45ed-bf26-112ec418cd6b |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53240-240-01 | CVS Health Non-Drowsy Nasal Decongestant | 48 in 1 PACKAGE | PILL | 48 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | 1 | |
| HYDROGENATED PALM KERNEL OIL | INACTIVE INGREDIENT | FM8D1RE2VP | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
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 |
|---|---|
| 53240-240 | 53240-240-01 |
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 |
|---|---|---|---|---|---|---|
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ENEMA / RECTAL | 0.01 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / VAGINAL | 0.4 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRAMUSCULAR | 87 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET / ORAL | 240 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | LIQUID / ORAL | NA | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET / SUBLINGUAL | 1.1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / ORAL | 907 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | INSERT / VAGINAL | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET / ORAL | 52 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION, EXTENDED RELEASE / ORAL | 37 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 900 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, CHEWABLE / ORAL | 84 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET, CHEWABLE / ORAL | 12 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 |
|---|---|---|---|---|---|---|
| cd2652b3-0228-4510-b7e1-f6b175914b78 | c4104df9-2f42-45ed-bf26-112ec418cd6b | 2015-10-06 | Warnings | cd2652b3-0228-4510-b7e1-f6b175914b78 c4104df9-2f42-45ed-bf26-112ec418cd6b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
