Chlorpheniramine Maleate

Chlorpheniramine Maleate is an FDA-registered drug product whose active ingredient is CHLORPHENIRAMINE MALEATE. It is labelled by PD-Rx Pharmaceuticals, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55289-560, application M012, label effective 20260810. It is one of 17 FDA drug label records sharing the active ingredient 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 CHLORPHENIRAMINE MALEATE are most often described in connection with: temporarily relieves, symptoms due, hay fever, upper respiratory, allergies sneezing, runny nose, itchy watery, eyes itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

Directions take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use

Warnings Do not use to make a child sleepy. Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness 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 (800-222-1222).

FDA lists 17 drug label records with 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Chlorpheniramine Maleate used for?
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

Who makes Chlorpheniramine Maleate?
PD-Rx Pharmaceuticals, Inc. is the labeler of record for Chlorpheniramine Maleate. 17 FDA label records share the active ingredient 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 Chlorpheniramine Maleate 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 Chlorpheniramine Maleate 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 CHLORPHENIRAMINE MALEATE?
Yes. 17 FDA drug label records list 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 Chlorpheniramine Maleate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.