Childrens Cough and Congestion, Childrens Cold and Cough Day, Night

Childrens Cough and Congestion, Childrens Cold and Cough Day, Night is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN. It is labelled by WALMART INC. and marketed as a human otc drug product. Identifiers on file: NDC 79903-414, application M012, label effective 20260519. It is one of 2 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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, DOXYLAMINE SUCCINATE, GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, symptoms cough, due minor, bronchial irritation, sleep helps, loosen phlegm, secretions rid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold symptoms: cough due to minor throat and bronchial irritation cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Directions do not take more than directed do not exceed 6 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children under 6 years do not use

Warnings Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

FDA lists 2 drug label records with DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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.

What is Childrens Cough and Congestion, Childrens Cold and Cough Day, Night used for?
Uses temporarily relieves these common cold symptoms: cough due to minor throat and bronchial irritation cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Who makes Childrens Cough and Congestion, Childrens Cold and Cough Day, Night?
WALMART INC. is the labeler of record for Childrens Cough and Congestion, Childrens Cold and Cough Day, Night. 2 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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.

Is Childrens Cough and Congestion, Childrens Cold and Cough Day, Night 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, DOXYLAMINE SUCCINATE, GUAIFENESIN?
Yes. 2 FDA drug label records list DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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 Childrens Cough and Congestion, Childrens Cold and Cough Day, Night 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.