Day and Night Multi Symptom Cold and Flu Relief

Day and Night Multi Symptom Cold and Flu Relief is an FDA-registered drug product whose active ingredient is DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF. It is labelled by Intrivo Diagnostics Inc. and marketed as a human otc drug product. Identifiers on file: NDC 83558-020, application M012, label effective 20231013. 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 DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, pains fever, runny nose. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use(s) temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing nasal congestion (Daytime only)

Directions Directions (Nighttime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 4 hours Children 4 to under 12 years: do not use Children under 4 years: ask a doctor Directions (Daytime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 6 hours Children 4 to under 12 years: do not use Children under 4 years: ask a doctor

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 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, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product to make a child sleep (Nighttime only) Ask a doctor before use if liver disease 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 trouble urinating due to an enlarged prostate gland glaucoma (Nighttime only) heart disease thyroid disease diabetes high blood sugar (Daytime 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 When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain 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. you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only) These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children Taking more than directed can cause serious health problems. 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.

What is Day and Night Multi Symptom Cold and Flu Relief used for?
Use(s) temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing nasal congestion (Daytime only)

Who makes Day and Night Multi Symptom Cold and Flu Relief?
Intrivo Diagnostics Inc. is the labeler of record for Day and Night Multi Symptom Cold and Flu Relief.

Is Day and Night Multi Symptom 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.

Has Day and Night Multi Symptom 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.