COLTALIN-DM

COLTALIN-DM is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by FORTUNE PHARMACAL COMPANY LIMITED taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51467-012, application M012, label effective 20260917. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, 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 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: hay fever, temporarily relieves, symptoms due, minor aches, pains headache, sore throat, nasal congestion, runny nose. 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 a cold, the flu, or hay fever: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sinus congestion and pressure ■ cough due to minor throat and bronchial irritation ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ promotes nasal and/or sinus drainage

Directions ■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor ■ children under 6 of age : consult a doctor

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin rash occurs, stop use and seek medical help right away.

FDA lists 3 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, 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 COLTALIN-DM used for?
Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sinus congestion and pressure ■ cough due to minor throat and bronchial irritation ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ promotes nasal and/or sinus drainage

Who makes COLTALIN-DM?
FORTUNE PHARMACAL COMPANY LIMITED is the labeler of record for COLTALIN-DM. 3 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, 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 COLTALIN-DM 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 COLTALIN-DM 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 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, 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 COLTALIN-DM 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.