PHENAGIL

PHENAGIL is an FDA-registered drug product whose active ingredient is PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE. It is labelled by Gil Pharmaceutical Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58552-322, application M012, label effective 20260902. It is one of 3 FDA drug label records sharing the active ingredient PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE. 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 HCL AND CHLORPHENIRAMINE MALEATE are most often described in connection with: temporarily relieves, symptoms due, hay fever, allergic rhinitis, upper respiratory, allergies runny, nose sneezing, itchy watery. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Directions Adults and Children12 years of age and over: take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period Children under 6 years of age: Consult a physician.

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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not exceed recommended dose • excitability may occur, especially in children • drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • symptoms do not improve within 7 days or occur with a fever. If pregnant or breast-feeding , ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

FDA lists 3 drug label records with PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE 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 PHENAGIL used for?
Uses Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Who makes PHENAGIL?
Gil Pharmaceutical Corp is the labeler of record for PHENAGIL. 3 FDA label records share the active ingredient PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE, 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 PHENAGIL come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is PHENAGIL 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 HCL AND CHLORPHENIRAMINE MALEATE?
Yes. 3 FDA drug label records list PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE 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 PHENAGIL 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.