Winco Foods Childrens Multi Symptom Cold

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

Winco Foods Childrens Multi Symptom Cold is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE manufactured by WINCO FOODS, LLC 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 20260807.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
WINCO FOODS, LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
67091-355
Application
M012
Label effective
20260807

About this product

Winco Foods Childrens Multi Symptom Cold is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE. It is labelled by WINCO FOODS, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 67091-355, application M012, label effective 20260807. It is one of 9 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE 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.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs, productive temporarily, relieves cough. 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) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant

Indications & Usage

Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ▪ the intensity of coughing ▪ the impulse to cough to help your child get to sleep ▪ nasal congestion due to a cold ▪ stuffy nose

Dosage & Administration

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 of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not get better within 7 days or occur with fever • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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 at 1-800-222-1222.

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DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

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DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE

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How products containing DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE compare

FDA lists 9 drug label records with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE 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.

Dosage formProductsManufacturerProducts
— — Reckitt Benckiser LLC 3
— — Pharmadel LLC 2
— — CVS PHARMACY, INC 1
— — SuperValu Inc., 1
— — WINCO FOODS, LLC 1

Frequently asked questions

What is Winco Foods Childrens Multi Symptom Cold 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: ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ▪ the intensity of coughing ▪ the impulse to cough to help your child get to sleep ▪ nasal congestion due to a cold …

Who makes Winco Foods Childrens Multi Symptom Cold?
WINCO FOODS, LLC is the labeler of record for Winco Foods Childrens Multi Symptom Cold. 9 FDA label records share the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE 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 Winco Foods Childrens Multi Symptom Cold 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 Winco Foods Childrens Multi Symptom Cold 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 HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?
Yes. 9 FDA drug label records list DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE 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 Winco Foods Childrens Multi Symptom Cold 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.