DRx Choice Childrens Stuffy Nose and Chest Congestion

DRx Choice Childrens Stuffy Nose and Chest Congestion is an FDA-registered drug product whose active ingredient is GUAIFENESIN AND PHENYLEPHRINE HCL. It is labelled by RARITAN PHARMACEUTICALS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-748, application M012, label effective 20260909. 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 GUAIFENESIN AND PHENYLEPHRINE HCL are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs, productive temporarily, relieves nasal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ nasal congestion due to a cold ▪ stuffy nose

Directions ▪ do not give more than 6 doses in any 24 hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor Age Dose Children 6 years to under 12 years 10 mL every 4 hours Children 4 years to under 6 years 5 mL every 4 hours Children under 4 years do not use

Warnings Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

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 Childrens Stuffy Nose and Chest Congestion used for?
Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ nasal congestion due to a cold ▪ stuffy nose

Who makes DRx Choice Childrens Stuffy Nose and Chest Congestion?
RARITAN PHARMACEUTICALS is the labeler of record for DRx Choice Childrens Stuffy Nose and Chest Congestion.

What form does DRx Choice Childrens Stuffy Nose 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 Childrens Stuffy Nose 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.

Has DRx Choice Childrens Stuffy Nose 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.