SEVERE COLD PLUS FLU DAYTIME NIGHTTIME

SEVERE COLD PLUS FLU DAYTIME NIGHTTIME is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE. It is labelled by CVS Pharmacy,Inc. and marketed as a human otc drug product. Identifiers on file: NDC 69842-546, application M012, label effective 20260814. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE. 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, AND DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, symptoms due, cold flu, minor aches, pains headache, sore throat, cough nasal, congestion sinus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves these symptoms due to a cold or flu: ▪ minor aches and pains ▪ headache ▪ sore throat ▪ cough ▪ nasal congestion ▪ sinus congestion and pressure ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ▪ temporarily reduces fever

Directions ▪ do not take more than the recommended dose ▪ take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. ▪ 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 packets in 24 hours, which is the maximum daily amount for this product ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is a skin or general allergic 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 ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ▪ 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. ▪ if you have ever had an allergic reaction to this product or any of its ingredients ▪ in children under 12 years of age Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficulty in urination due to enlargement of the prostate gland ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough with excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if ▪ 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. ▪ nervousness, dizziness, or sleeplessness occurs 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away.

FDA lists 2 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE 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 SEVERE COLD PLUS FLU DAYTIME NIGHTTIME used for?
Uses ▪ temporarily relieves these symptoms due to a cold or flu: ▪ minor aches and pains ▪ headache ▪ sore throat ▪ cough ▪ nasal congestion ▪ sinus congestion and pressure ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ▪ temporarily reduces fever

Who makes SEVERE COLD PLUS FLU DAYTIME NIGHTTIME?
CVS Pharmacy,Inc. is the labeler of record for SEVERE COLD PLUS FLU DAYTIME NIGHTTIME. 2 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is SEVERE COLD PLUS FLU DAYTIME NIGHTTIME 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, AND DOXYLAMINE SUCCINATE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE 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 COLD PLUS FLU DAYTIME NIGHTTIME 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.