CVS Severe Congestion and Pain Relief

CVS Severe Congestion and Pain Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE. It is labelled by CVS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69842-717, application M012, label effective 20260819. It is one of 7 FDA drug label records sharing the active ingredient ACETAMINOPHEN, GUAIFENESIN, AND 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, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, nasal congestion, headache minor, pains sinus, drainage helps, loosens phlegm, thin bronchial, secretions rid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves: ▪ nasal congestion ▪ headache ▪ minor aches and pains ▪ sinus congestion and pressure ▪ temporarily promotes nasal and/or sinus drainage ▪ helps loosens phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Directions ▪ do not take more than directed (see Overdose warning ) ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours ▪ children under 12 years of age: do not use

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: ▪ more than 6 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks daily 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. 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. 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 ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ▪ cough that occurs with too much phlegm (mucus) 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 • nervousness, dizziness, or sleeplessness occur • 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 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. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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.

FDA lists 7 drug label records with ACETAMINOPHEN, GUAIFENESIN, AND 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 Congestion and Pain Relief used for?
Uses ▪ temporarily relieves: ▪ nasal congestion ▪ headache ▪ minor aches and pains ▪ sinus congestion and pressure ▪ temporarily promotes nasal and/or sinus drainage ▪ helps loosens phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Who makes CVS Severe Congestion and Pain Relief?
CVS is the labeler of record for CVS Severe Congestion and Pain Relief. 7 FDA label records share the active ingredient ACETAMINOPHEN, GUAIFENESIN, AND 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 Congestion and Pain 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 Severe Congestion and Pain 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 ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?
Yes. 7 FDA drug label records list ACETAMINOPHEN, GUAIFENESIN, AND 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 Congestion and Pain 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.