Nighttime Severe Cold and Flu Maximum Strength mini softgels

Nighttime Severe Cold and Flu Maximum Strength mini softgels is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL. It is labelled by Shield Pharmaceuticals Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83059-0074, application M012, label effective 20260826. It is one of 22 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms due, cold flu, minor aches, pains headache, cough nasal, sinus congestion, sore throat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces fever runny nose, sneezing

Directions do not take more than the recommended dose adults & children 12 yrs & over: take 2 softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor children under 12 yrs: do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock. If a skin or general allergic 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use in children or to sedate children.

FDA lists 22 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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 Nighttime Severe Cold and Flu Maximum Strength mini softgels used for?
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces fever runny nose, sneezing

Who makes Nighttime Severe Cold and Flu Maximum Strength mini softgels?
Shield Pharmaceuticals Corp is the labeler of record for Nighttime Severe Cold and Flu Maximum Strength mini softgels. 22 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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 Nighttime Severe Cold and Flu Maximum Strength mini softgels 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 Severe Cold and Flu Maximum Strength mini softgels 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, PHENYLEPHRINE HCL?
Yes. 22 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, 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 Nighttime Severe Cold and Flu Maximum Strength mini softgels 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.