DAYTIME SEVERE COLD AND FLU 325 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · CAPSULE · CVS HEALTH CORP

No Recall HistoryCurrently in Shortage

Plain English

DAYTIME SEVERE COLD AND FLU is a capsule containing acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by CVS HEALTH CORP.

Key Facts

Brand Name: DAYTIME SEVERE COLD AND FLU
Generic Name: Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product): 51316-525
Manufacturer: CVS HEALTH CORP
Strength: 325 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 02/01/2025

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 contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. It is a capsule taken oral. Consult your doctor for specific uses.

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 HBr, Guaifenesin, Phenylephrine HCl. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl.

What is the NDC code for DAYTIME SEVERE COLD AND FLU 325 mg/1?

The NDC (National Drug Code) for DAYTIME SEVERE COLD AND FLU 325 mg/1 is 51316-525, listed by CVS HEALTH CORP.

Product NDC

51316-525

Package NDC

51316-525-24

Other Acetaminophen, Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)