Drugplain

Nighttime Cold and Flu Relief 650 mg/30mL

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate · LIQUID · Safeway, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Nighttime Cold And Flu Relief is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine (a sleep aid) to help relieve cold and flu symptoms at night. It is taken by mouth and is designed to help you rest while managing cough, congestion, aches, and fever associated with colds and the flu.

Key Facts

Brand Name
Nighttime Cold and Flu Relief
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
NDC Code (Product)
21130-044
Manufacturer
Safeway, Inc.
Strength
650 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/30/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,387 reports
fatigue20,435 reports
drug ineffective18,156 reports
pain18,104 reports
nausea17,626 reports
headache16,715 reports
toxicity to various agents15,539 reports
dyspnoea14,576 reports
arthralgia14,309 reports
pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms minor aches and pains headache sore throat fever runny nose and sneezing cough due to minor throat and bronchial irritation

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Warnings

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 everyday 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease glaucoma cough that occur…

Frequently Asked Questions

What is Nighttime Cold and Flu Relief used for?

Nighttime Cold And Flu Relief is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine (a sleep aid) to help relieve cold and flu symptoms at night. It is taken by mouth and is designed to help you rest while managing cough, congestion, aches, and fever associated with colds and the flu.

Is Nighttime Cold and Flu Relief a controlled substance?

Nighttime Cold and Flu Relief is not classified as a controlled substance by the DEA.

What is the generic name for Nighttime Cold and Flu Relief?

The generic name for Nighttime Cold and Flu Relief is Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate. There are 12 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate.

What is the NDC code for Nighttime Cold and Flu Relief 650 mg/30mL?

The NDC (National Drug Code) for Nighttime Cold and Flu Relief 650 mg/30mL is 21130-044, listed by Safeway, Inc..

Product NDC

21130-044

Package NDC

21130-044-08

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

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