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Nasal Decongestant PE
phenylephrine hcl · Nasal Decongestant PE is an over-the-counter drug containing phenylephrine hcl, made by 3 manufacturers.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 3
- + 1 repackager labels
temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Drug facts
- Generic name
- phenylephrine hcl
- Active ingredients
- Phenylephrine Hydrochloride
- Dosage forms
- Tablet, film coated
- Label holder
- Walgreen Company
- FDA application
- M012
- Label updated
- 04/13/2026
Active ingredients
(in each tablet) Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
Temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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
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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland
When using this product
Do not exceed recommended dosage.
Stop use and ask a doctor
Nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever
Pregnancy or breastfeeding
Ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Other information
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Questions?
1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Forms and strengths
From the FDA NDC Directory · 4 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, film coated | 10 mg | oral | 4 |
Manufacturers and labels
4 FDA labels · 1 from repackagers
- Walgreen CompanyShown hereM012 · Label 04/13/2026 · NDC 0363-4531Full label
- Better Living Brands, LLCM012 · Label 03/06/2026 · NDC 21130-453Full label
- H E BM012 · Label 12/04/2025 · NDC 37808-453Full label
Repackager labels (1)
- A-S Medication Solutions11/13/2024
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing05/06/2026Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03Wells Pharma of Houston LLC · cGMP deviations.
- Class IIDrugOngoing12/17/2025Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL...Fagron Compounding Services · Incorrect Product Formulation
- Class IIDrugOngoing12/10/2025Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave...Park Avenue Compounding · CGMP Deviations
- Class IIIDrug07/30/2025Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL...Imprimis NJOF, LLC · Sub-Potent Drug: Subpotent assay results during stability testing.
- Class IIDrugOngoing04/30/2025PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only...Denver Solutions, LLC DBA Leiters Health · Lack of Assurance of Sterility: Leaking/damaged syringes.
Nasal Decongestant PE: common questions
- What is Nasal Decongestant PE used for?
- temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- Is Nasal Decongestant PE a prescription drug?
- No. Nasal Decongestant PE is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Nasal Decongestant PE?
- Yes. Other FDA-listed products with the same active ingredients include Nasal, Nasal Decongestant PE Maximum Strength, Equate Nasal, Phenylephrine Hydrochloride.
- Who makes Nasal Decongestant PE?
- 3 manufacturers list Nasal Decongestant PE with the FDA, including Walgreen Company, Better Living Brands, LLC, H E B.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/13/2026 · Label text is shown as published by the manufacturer. Not medical advice