Severe Congestion and Cough Multi-Symptom Maximum Strength
Severe Congestion and Cough Multi-Symptom Maximum Strength 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 20260710.
- Generic name
- DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
- Manufacturer
- CVS Pharmacy
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 59779-648
- Application
- M012
- Label effective
- 20260710
About this product
Severe Congestion and Cough Multi-Symptom Maximum Strength 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 59779-648, application M012, label effective 20260710. 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: temporarily relieves, cough due, minor throat, bronchial irritation, common cold, inhaled irritants, intensity coughing, nasal congestion. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing nasal congestion due to a cold the impulse to cough to help you get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions do not take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use
Warnings
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 high blood pressure heart disease diabetes difficulty in urination due to enlargement of the prostate gland thyroid disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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 7 days, 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.
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View labelHow 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Walgreen Company | 3 |
| — | — | CVS PHARMACY | 2 |
| — | — | TOPCO ASSOCIATES LLC | 2 |
| — | — | CVS Pharmacy | 1 |
| — | — | Chain Drug Marketing Association, Inc. | 1 |
Frequently asked questions
What is Severe Congestion and Cough Multi-Symptom Maximum Strength used for?
Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing nasal congestion due to a cold the impulse to cough to help you get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Severe Congestion and Cough Multi-Symptom Maximum Strength?
CVS Pharmacy is the labeler of record for Severe Congestion and Cough Multi-Symptom Maximum Strength. 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 Severe Congestion and Cough Multi-Symptom Maximum Strength 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 Severe Congestion and Cough Multi-Symptom Maximum Strength 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 Severe Congestion and Cough Multi-Symptom Maximum Strength 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.