DRx Choice Children daytime Cough and Chest Congestion

DRx Choice Children daytime Cough and Chest Congestion is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR AND GUAIFENESIN. It is labelled by RARITAN PHARMACEUTICALS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-747, application M012, label effective 20260909. It is one of 7 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR AND GUAIFENESIN. 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 DEXTROMETHORPHAN HBR AND GUAIFENESIN are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, cold helps, loosen phlegm, secretions drain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter Age Dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and older 20 mL every 4 hours

Warnings

FDA lists 7 drug label records with DEXTROMETHORPHAN HBR AND GUAIFENESIN 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 DRx Choice Children daytime Cough and Chest Congestion used for?
Uses ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Who makes DRx Choice Children daytime Cough and Chest Congestion?
RARITAN PHARMACEUTICALS is the labeler of record for DRx Choice Children daytime Cough and Chest Congestion. 7 FDA label records share the active ingredient DEXTROMETHORPHAN HBR AND GUAIFENESIN, 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 DRx Choice Children daytime Cough and Chest Congestion 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 DRx Choice Children daytime Cough and Chest Congestion 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 DEXTROMETHORPHAN HBR AND GUAIFENESIN?
Yes. 7 FDA drug label records list DEXTROMETHORPHAN HBR AND GUAIFENESIN 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 DRx Choice Children daytime Cough and Chest Congestion 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.