CVS Daytime Cold and Flu Relief

CVS Daytime Cold and Flu Relief is an FDA-registered drug product whose active ingredient is ACETAMINOHPEN, 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 51316-727, application M012, label effective 20260818. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOHPEN, 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.

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

Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduce swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Directions • take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hours Adults & children 12 yrs & over 30 mL every 4 hrs. Children 4 to under 12 yrs Ask a doctor Children under 4 yrs. Do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4 doses in 24 hrs which is maximum daily amount for this product • taken 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 • with any other drug containing acetaminophen (prescription or non-prescription). 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. 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) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • pain, nasal congestion or cough 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 a 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 2 drug label records with ACETAMINOHPEN, 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.

What is CVS Daytime Cold and Flu Relief used for?
Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduce swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • help loosen phlegm (mucus) and thin bronchial …

Who makes CVS Daytime Cold and Flu Relief?
CVS PHARMACY is the labeler of record for CVS Daytime Cold and Flu Relief. 2 FDA label records share the active ingredient ACETAMINOHPEN, 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 CVS Daytime Cold and Flu Relief 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 Daytime Cold and Flu Relief 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 ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL?
Yes. 2 FDA drug label records list ACETAMINOHPEN, 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 CVS Daytime Cold and Flu Relief 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.