Chlorphen-12

Chlorphen-12 is an FDA-registered drug product whose active ingredient is CHLORPHENIRAMINE MALEATE. It is labelled by KVK-Tech, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 10702-017, application ANDA040829, label effective 20181219. It is one of 9 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, following symptoms, due hay, 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 the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

DIRECTIONS adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: ask a doctor

WARNINGS Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alchohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 If pregnant or breast-feeding, ask a health professional before use

FDA lists 9 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 Chlorphen-12 used for?
USES temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

Who makes Chlorphen-12?
KVK-Tech, Inc. is the labeler of record for Chlorphen-12. 9 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 Chlorphen-12 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 Chlorphen-12 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. 9 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 Chlorphen-12 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.