Drugplain

DAY-TIME Cold and Flu 325 mg/15mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE · LIQUID · DeMoulas Market Basket

No Recall HistoryCurrently in Shortage
Plain English

DAY-TIME Cold and Flu is a liquid containing acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride at 325 mg/15mL, taken oral. Manufactured by DeMoulas Market Basket.

Key Facts

Brand Name
DAY-TIME Cold and Flu
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
53942-506
Manufacturer
DeMoulas Market Basket
Strength
325 mg/15mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
09/12/2012

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
choking1 reports
erythema1 reports
heart rate increased1 reports
intentional product misuse1 reports
medication error1 reports
peripheral swelling1 reports
pharyngeal swelling1 reports
product contamination microbial1 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 • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water 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 DAY-TIME Cold and Flu used for?

DAY-TIME Cold and Flu contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. It is a liquid taken oral. Consult your doctor for specific uses.

Is DAY-TIME Cold and Flu a controlled substance?

DAY-TIME Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for DAY-TIME Cold and Flu?

The generic name for DAY-TIME Cold and Flu is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. There are 11 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for DAY-TIME Cold and Flu 325 mg/15mL?

The NDC (National Drug Code) for DAY-TIME Cold and Flu 325 mg/15mL is 53942-506, listed by DeMoulas Market Basket.