Cold and Flu Day and Night, Severe

Cold and Flu Day and Night, Severe is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. It is labelled by ARMY AND AIR FORCE EXCHANGE SERVICE and marketed as a human otc drug product. Identifiers on file: NDC 55301-547, application M012, label effective 20260420. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL are most often described in connection with: only helps, temporarily relieves, common cold, flu symptoms, cough headache, sore throat, nasal congestion, minor aches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold and flu symptoms: cough headache sore throat nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 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 Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time.

FDA lists 3 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 Cold and Flu Day and Night, Severe used for?
Uses temporarily relieves these common cold and flu symptoms: cough headache sore throat nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Who makes Cold and Flu Day and Night, Severe?
ARMY AND AIR FORCE EXCHANGE SERVICE is the labeler of record for Cold and Flu Day and Night, Severe. 3 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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.

Is Cold and Flu Day and Night, Severe 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, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL?
Yes. 3 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 Cold and Flu Day and Night, Severe 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.