Nighttime Severe Cold and Cough

Nighttime Severe Cold and Cough is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE. It is labelled by RARITAN PHARMACEUTICALS INC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-541, application M012, label effective 20260908. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE. 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, DIPHENHYDRAMINE, PHENYLEPHRINE are most often described in connection with: temporarily relieves, symptoms due, cold minor, sore throat, pain headache, sinus congestion, runny nose, sneezing itchy. 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: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever

Directions ▪ do not use more than directed ▪ take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

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.

FDA lists 3 drug label records with ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 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 Cough used for?
Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever

Who makes Nighttime Severe Cold and Cough?
RARITAN PHARMACEUTICALS INC is the labeler of record for Nighttime Severe Cold and Cough. 3 FDA label records share the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE, 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 Cough 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 Cough 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, DIPHENHYDRAMINE, PHENYLEPHRINE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 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 Cough 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.