Neo-Synephrine Severe

Neo-Synephrine Severe is an FDA-registered drug product whose active ingredient is PHENYLEPHRINE HYDROCHLORIDE. It is labelled by BF ASCHER AND CO INC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 0225-0811, application M012, label effective 20260623. It is one of 44 FDA drug label records sharing the active ingredient PHENYLEPHRINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, nasal congestion, due common, cold hay, fever upper, respiratory allergies, pressure shrinks, swollen membranes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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

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.

FDA lists 44 drug label records with PHENYLEPHRINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Neo-Synephrine Severe 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.

Who makes Neo-Synephrine Severe?
BF ASCHER AND CO INC is the labeler of record for Neo-Synephrine Severe. 44 FDA label records share the active ingredient PHENYLEPHRINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Neo-Synephrine Severe come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Neo-Synephrine Severe prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PHENYLEPHRINE HYDROCHLORIDE?
Yes. 44 FDA drug label records list PHENYLEPHRINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Neo-Synephrine Severe been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.