Drugplain

severe cold and flu relief 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl · SOLUTION · Rite Aid Corporation

No Recall HistoryCurrently in Shortage
Plain English

Severe Cold And Flu Relief is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), doxylamine succinate (a sleep aid), and phenylephrine (a nasal decongestant) to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to address cough, congestion, aches, fever, and sleep disruption associated with cold and flu.

Key Facts

Brand Name
severe cold and flu relief
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
NDC Code (Product)
11822-0763
Manufacturer
Rite Aid Corporation
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/27/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents2 reports
anaphylactic reaction1 reports
blood glucose increased1 reports
choking1 reports
diarrhoea1 reports
dizziness1 reports
erythema1 reports
heart rate increased1 reports
intentional product misuse1 reports
medication error1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and or sinus drainage helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Dosage & Administration

Directions take only as directed (see overdose warning) do not take more than 4 doses in any 24 hours measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product adults and children12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years 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 adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blistere 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 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,…

Frequently Asked Questions

What is severe cold and flu relief used for?

Severe Cold And Flu Relief is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), doxylamine succinate (a sleep aid), and phenylephrine (a nasal decongestant) to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to address cough, congestion, aches, fever, and sleep disruption associated with cold and flu.

Is severe cold and flu relief a controlled substance?

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

What is the generic name for severe cold and flu relief?

The generic name for severe cold and flu relief 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 severe cold and flu relief 650 mg/30mL?

The NDC (National Drug Code) for severe cold and flu relief 650 mg/30mL is 11822-0763, listed by Rite Aid Corporation.

Product NDC

11822-0763

Package NDC

11822-0763-1

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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)