Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is an FDA-registered drug product whose active ingredient is CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE. It is labelled by Aurohealth LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58602-703, application ANDA212409, label effective 20260825. It is one of 3 FDA drug label records sharing the active ingredient CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, symptoms due, hay fever, upper respiratory, allergies runny, nose sneezing, 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: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

FDA lists 3 drug label records with CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride used for?
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Who makes Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?
Aurohealth LLC is the labeler of record for Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride. 3 FDA label records share the active ingredient CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 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 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE?
Yes. 3 FDA drug label records list CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 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.