Cold Childrens, Multi Symptom

DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ORAL HUMAN OTC DRUG

Cold Childrens, Multi Symptom is an FDA drug label for the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL manufactured by CVS PHARMACY 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 20260529.

Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
CVS PHARMACY
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
69842-570
Application
M012
Label effective
20260529

About this product

Cold Childrens, Multi Symptom is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. It is labelled by CVS PHARMACY taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69842-570, application M012, label effective 20260529. It is one of 14 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. 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, PHENYLEPHRINE HCL 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) Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

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 stuffy nose nasal congestion due to a cold the intensity of coughing the impulse to cough to help the child get to sleep

Dosage & Administration

Directions do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 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 diabetes heart disease thyroid disease high blood pressure persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) When using this product do not exceed recommended dosage. 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL

Childrens Mucus Cough and Congestion Relief

Walgreen Company View label

Giltuss Cough and Cold

Gil Pharmaceutical Corp View label

Maximum Strength Mucus Relief

Hyvee Inc View label

Mucus Relief Childrens

TOPCO ASSOCIATES LLC View label

Mucus Relief Severe Congestion and Cough

Chain Drug Marketing Association, Inc. View label

Mucus Relief Severe Congestion and Cough

TOPCO ASSOCIATES LLC View label

Mucus Relief Severe Congestion and Cough Maximum Strength

Raritan Pharmaceuticals Inc View label

How products containing DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL compare

FDA lists 14 drug label records with DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL 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
— — Walgreen Company 3
— — CVS PHARMACY 2
— — TOPCO ASSOCIATES LLC 2
— — CVS Pharmacy 1
— — Chain Drug Marketing Association, Inc. 1

Frequently asked questions

What is Cold Childrens, Multi Symptom 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 stuffy nose nasal congestion due to a cold the intensity of coughing the impulse to cough to help the child get to sleep

Who makes Cold Childrens, Multi Symptom?
CVS PHARMACY is the labeler of record for Cold Childrens, Multi Symptom. 14 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, 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 Cold Childrens, Multi Symptom 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 Cold Childrens, Multi Symptom 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, PHENYLEPHRINE HCL?
Yes. 14 FDA drug label records list DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL 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 Cold Childrens, Multi Symptom 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.