Drugplain

nitetime cold and flu 650 mg/30mL

Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl · SOLUTION · Meijer Distribution Inc

No Recall HistoryCurrently in Shortage
Plain English

Nitetime Cold And Flu is an over-the-counter oral liquid medication that combines acetaminophen (pain reliever and fever reducer), dextromethorphan (cough suppressant), doxylamine (antihistamine for sleep), and phenylephrine (nasal decongestant) to relieve multiple cold and flu symptoms. This combination product is designed to help with cough, congestion, aches, fever, and sleeplessness associated with cold and flu.

Key Facts

Brand Name
nitetime cold and flu
Generic Name
Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
NDC Code (Product)
41250-811
Manufacturer
Meijer Distribution Inc
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/23/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

contusion1 reports
dehydration1 reports
drug toxicity1 reports
hepatic necrosis1 reports
hepatic steatosis1 reports
suspected suicide1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings

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 …

Frequently Asked Questions

What is nitetime cold and flu used for?

Nitetime Cold And Flu is an over-the-counter oral liquid medication that combines acetaminophen (pain reliever and fever reducer), dextromethorphan (cough suppressant), doxylamine (antihistamine for sleep), and phenylephrine (nasal decongestant) to relieve multiple cold and flu symptoms. This combination product is designed to help with cough, congestion, aches, fever, and sleeplessness associated with cold and flu.

Is nitetime cold and flu a controlled substance?

nitetime cold and flu is not classified as a controlled substance by the DEA.

What is the generic name for nitetime cold and flu?

The generic name for nitetime cold and flu is Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl. There are 12 other brand versions of Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl.

What is the NDC code for nitetime cold and flu 650 mg/30mL?

The NDC (National Drug Code) for nitetime cold and flu 650 mg/30mL is 41250-811, listed by Meijer Distribution Inc.

Product NDC

41250-811

Package NDC

41250-811-40

Other Acetaminophen, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)