Nighttime Cold and Flu Multi Symptom Relief

Nighttime Cold and Flu Multi Symptom Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE. It is labelled by Shield Pharmaceuticals Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83059-0177, application M012, label effective 20260902. It is one of 25 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 HBR, DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, aches pains, fever runny. 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: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over: 2 Softgels with water every 6 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 4000 mg in 24 hrs, which is the maximum daily amount for this product • 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. 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.

FDA lists 25 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 Nighttime Cold and Flu Multi Symptom Relief used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Who makes Nighttime Cold and Flu Multi Symptom Relief?
Shield Pharmaceuticals Corp is the labeler of record for Nighttime Cold and Flu Multi Symptom Relief. 25 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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.

What form does Nighttime Cold and Flu Multi Symptom 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 Nighttime Cold and Flu Multi Symptom 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, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE?
Yes. 25 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 Nighttime Cold and Flu Multi Symptom 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.