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Neo-Synephrine Maximum
phenylephrine hydrochloride · Neo-Synephrine Maximum is an over-the-counter drug containing phenylephrine hydrochloride, made by BF ASCHER AND CO INC.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Nasal
- Manufacturers
- 1
Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely Temporarily restores freer breathing through the nose.
Drug facts
- Generic name
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine Hydrochloride
- Dosage forms
- Spray
- Label holder
- BF ASCHER AND CO INC
- FDA application
- M012
- Label updated
- 11/16/2023
Active ingredients
Phenylephrine hydrochloride 1.0%
Purpose
Nasal decongestant
Uses
Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely Temporarily restores freer breathing through the nose.
Directions
To spray, squeeze bottle quickly and firmly adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours Children under 12 years of age: ask a doctor
Warnings
When using this product: temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur. use of this container by more than one person may spread infection. use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
Do not use
If you have ever had an allergic reaction to this product or any of its ingredients. Do not use more than directed. Do not use for more than 3 days.
Ask a doctor before use
Heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and as a doctor if symptoms persist.
Stop use and ask a doctor
Symptoms persist.
Pregnancy or breastfeeding
Ask a health professional before use.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Other information
Store at room temperature, 59º - 86º F (15º -30º C) Retain carton for future reference on full labeling
Inactive ingredients
Anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate
Questions?
Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Spray | 1 g/100mL | nasal | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 3,734 reports that list phenylephrine hydrochloride, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Off label use1,329
- Pemphigus1,039
- Joint swelling1,005
- Pain981
- Drug ineffective970
- Rheumatoid arthritis960
- Infusion related reaction953
- Systemic lupus erythematosus948
- Pericarditis944
- Maternal exposure during pregnancy940
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- BF ASCHER AND CO INCShown hereM012 · Label 11/16/2023 · NDC 0225-0810Full label
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.
Neo-Synephrine Maximum: common questions
- What is Neo-Synephrine Maximum used for?
- Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely Temporarily restores freer breathing through the nose.
- Is Neo-Synephrine Maximum a prescription drug?
- No. Neo-Synephrine Maximum is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Neo-Synephrine Maximum?
- Yes. Other FDA-listed products with the same active ingredients include Nasal, Nasal Decongestant PE, Nasal Decongestant PE Maximum Strength, Equate Nasal.
- Who makes Neo-Synephrine Maximum?
- BF ASCHER AND CO INC lists Neo-Synephrine Maximum with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/16/2023 · Label text is shown as published by the manufacturer. Not medical advice