COLDTAC Plus

COLDTAC Plus is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by OPMX LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69729-143, application M012, label effective 20260723. 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, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, common cold, nasal congestion, hay fever, upper respiratory, pressure helps, decongest sinus, passages restores. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Relieves sinus congestion and pressure, helps decongest sinus openings and passages Restores freer breathing Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps

Directions: Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Warnings: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 8 tablets in 24 hours With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure 3 or more alcoholic drinks every day while using this product

What is COLDTAC Plus used for?
Uses Temporarily Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Relieves sinus congestion and pressure, helps decongest sinus openings and passages Restores freer breathing Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive Suppresses cough due to minor throat and bronchial irritation associated with a cold or …

Who makes COLDTAC Plus?
OPMX LLC is the labeler of record for COLDTAC Plus.

What form does COLDTAC Plus 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 COLDTAC Plus 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.

Has COLDTAC Plus 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.