Kids Cough and Chest Congestion

DEXTROMETHORPHAN HBR, GUAIFENESIN ORAL HUMAN OTC DRUG

Kids Cough and Chest Congestion is an FDA drug label for the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN manufactured by Genexa Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260528.

Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer
Genexa Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
69676-0037
Application
M012
Label effective
20260528

About this product

Kids Cough and Chest Congestion is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN. It is labelled by Genexa Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69676-0037, application M012, label effective 20260528. It is one of 33 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, 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.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN HBR, GUAIFENESIN are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, common cold, inhaled irritants, helps loosen, phlegm mucus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each 5 mL) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions SHAKE WELL BEFORE EACH USE do not give more than 6 doses in any 24-hour period use only with enclosed dose cup. Do not use with any other dosing device. mL = milliliter children 6 to under 12 years 5 mL - 10 mL every 4 hours children 4 to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use

Warnings

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. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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How products containing DEXTROMETHORPHAN HBR, GUAIFENESIN compare

FDA lists 33 drug label records with DEXTROMETHORPHAN HBR, 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.

Dosage formProductsManufacturerProducts
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4
— — Akron Pharma Inc. 2
— — Amerisource Bergen 2
— — CVS PHARMACY 2
— — DOLGENCORP, LLC 2

Frequently asked questions

What is Kids Cough and Chest Congestion used for?
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Who makes Kids Cough and Chest Congestion?
Genexa Inc. is the labeler of record for Kids Cough and Chest Congestion. 33 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, 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 Kids 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 Kids 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, GUAIFENESIN?
Yes. 33 FDA drug label records list DEXTROMETHORPHAN HBR, 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 Kids Cough and Chest Congestion 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.