Drugplain

DayTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride · CAPSULE, LIQUID FILLED · Topco Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

DayTime SEVERE Cold and Flu Relief SOFTGELS is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
DayTime SEVERE Cold and Flu Relief SOFTGELS
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
NDC Code (Product)
76162-636
Manufacturer
Topco Associates LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
12/11/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • minor aches & 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 • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels 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 8 softgels in 24 hours, which is the maximum daily amount for this product • 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. Ask a doctor before use

Frequently Asked Questions

What is DayTime SEVERE Cold and Flu Relief SOFTGELS used for?

DayTime SEVERE Cold and Flu Relief SOFTGELS contains Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is DayTime SEVERE Cold and Flu Relief SOFTGELS a controlled substance?

DayTime SEVERE Cold and Flu Relief SOFTGELS is not classified as a controlled substance by the DEA.

What is the generic name for DayTime SEVERE Cold and Flu Relief SOFTGELS?

The generic name for DayTime SEVERE Cold and Flu Relief SOFTGELS 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 Relief SOFTGELS 325 mg/1?

The NDC (National Drug Code) for DayTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1 is 76162-636, listed by Topco Associates LLC.