Drugplain

daytime severe cold and flu 325 mg/15mL

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride · SOLUTION · Walgreen Company

No Recall HistoryCurrently in Shortage
Plain English

Daytime Severe Cold And Flu is an over-the-counter liquid medication that combines a pain reliever, cough suppressant, expectorant, and decongestant to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to address congestion, cough, fever, and general aches and pains associated with colds and the flu.

Key Facts

Brand Name
daytime severe cold and flu
Generic Name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
NDC Code (Product)
0363-5001
Manufacturer
Walgreen Company
Strength
325 mg/15mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
07/08/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

abdominal pain2 reports
back pain2 reports
dry mouth2 reports
heart rate increased2 reports
nasal congestion2 reports
paraesthesia2 reports
tachycardia2 reports
toxicity to various agents2 reports
adenomyosis1 reports
anaphylactic reaction1 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 • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use Other information • each 15 mL contains: sodium 6 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses 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 • 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 produc…

Frequently Asked Questions

What is daytime severe cold and flu used for?

Daytime Severe Cold And Flu is an over-the-counter liquid medication that combines a pain reliever, cough suppressant, expectorant, and decongestant to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to address congestion, cough, fever, and general aches and pains associated with colds and the flu.

Is daytime severe cold and flu a controlled substance?

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

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

The generic name for daytime severe cold and flu is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride.

What is the NDC code for daytime severe cold and flu 325 mg/15mL?

The NDC (National Drug Code) for daytime severe cold and flu 325 mg/15mL is 0363-5001, listed by Walgreen Company.

Product NDC

0363-5001

Package NDC

0363-5001-40

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)