CVS Severe Multi-Symptom Cough Cold Flu

CVS Severe Multi-Symptom Cough Cold Flu is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by CVS PHARMACY taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51316-630, application M012, label effective 20260814. It is one of 13 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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.

Across FDA labelling, products containing ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, symptoms occurring, cold flu, cough due, minor throat, bronchial irritation, nasal congestion, pains sore. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ nasal congestion ▪ sinus congestion and pressure ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Directions ▪ do not take more than 6 doses in any 24-hour period ▪ do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ ml = milliliter ▪ this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 ml every 4 hours children under 12 years do not use

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 doses in any 24-hour period, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking any other oral nasal decongestant or stimulant ▪ taking any other pain reliever/fever reducer When using this product do not use more than directed Stop use and ask a doctor if ▪ you get nervous, dizzy, or sleepless ▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back or occurs with rash or headache that lasts. 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 at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

FDA lists 13 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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.

What is CVS Severe Multi-Symptom Cough Cold Flu used for?
Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ nasal congestion ▪ sinus congestion and pressure ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Who makes CVS Severe Multi-Symptom Cough Cold Flu?
CVS PHARMACY is the labeler of record for CVS Severe Multi-Symptom Cough Cold Flu. 13 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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 CVS Severe Multi-Symptom Cough Cold Flu 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 CVS Severe Multi-Symptom Cough Cold Flu 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 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?
Yes. 13 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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 CVS Severe Multi-Symptom Cough Cold Flu 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.