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
Nasal Decongestant PE
- Manufacturer
- Bi-Mart | ELYSIUM PHARMACEUTICALS LIMITED
- Effective date
- 2025-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:57:52
Label at a glance#
ProductNasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections
Dosage and administration
adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor
Storage and handling
each tablet contains: phosphorus 10 mg store between 20°-25°C (68°-77°F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Phenylephrine HCl 10mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Warnings
Do not use ifyou 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.
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
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 (1-800 222-1222) right away.
Directions
- adults and children 12 years and over:take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years:ask a doctor
Other Information
- each tablet contains:phosphorus 10 mg
- store between 20°-25°C (68°-77°F)
- protect from excessive moisture
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients
Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose
Questions?
call toll free 1-844-912-4012
SPL UNCLASSIFIED SECTION
Distributed by:
BI-MART
Eugene, OR 97402
PRINCIPAL DISPLAY PANEL-36 Count
NDC 37835-651-36
Compare to the active ingredients in Sudafed PE® Sinus Congestion*
NON-DROWSY
NASAL DECONGESTANT PE
Phenylephrine HCl 10 mg
Relieves: Nasal & Sinus Congestion & Sinus Pressure
36 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.
PRINCIPAL DISPLAY PANEL-100 Count
NDC 37835-651-01
Compare to the active ingredients in Sudafed PE® Sinus Congestion*
NON-DROWSY
NASAL DECONGESTANT PE
Phenylephrine HCl 10 mg
Relieves: Nasal & Sinus Congestion & Sinus Pressure
100 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37835-651-01 | Nasal Decongestant PE | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 37835-651-36 | Nasal Decongestant PE | 36 in 1 BOTTLE | TABLET | 36 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Nasal Decongestant PE
- PHENYLEPHRINE HYDROCHLORIDE
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- DICALCIUM PHOSPHATE
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37835-651 | 37835-651-36, 37835-651-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DICALCIUM PHOSPHATE | L11K75P92J | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Bi-Mart | d208cb6f-e142-4aa3-959b-e6b601df76c1 | 2025-03-01 | Warnings | 37835-651-36 37835-651-01 37835-651 37835065136 37835065101 3127723a-459d-0ab2-e063-6394a90ad329 d208cb6f-e142-4aa3-959b-e6b601df76c1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.