Drugplain

Daytime Cold and Flu Relief 325 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl · CAPSULE, LIQUID FILLED · SALADO SALES INC.

No Recall HistoryCurrently in Shortage
Plain English

Daytime Cold And Flu Relief is an over-the-counter medication in capsule form that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a decongestant) to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to temporarily reduce fever, cough, and nasal congestion associated with colds and the flu.

Key Facts

Brand Name
Daytime Cold and Flu Relief
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
NDC Code (Product)
57243-604
Manufacturer
SALADO SALES INC.
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/23/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

palpitations2 reports
acute sinusitis1 reports
anxiety1 reports
aspartate aminotransferase increased1 reports
asthenopia1 reports
candida infection1 reports
chest discomfort1 reports
confusional state1 reports
epistaxis1 reports
fatigue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

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 Daytime Cold and Flu Relief used for?

Daytime Cold And Flu Relief is an over-the-counter medication in capsule form that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a decongestant) to help relieve multiple cold and flu symptoms. This combination product is taken by mouth and is designed to temporarily reduce fever, cough, and nasal congestion associated with colds and the flu.

Is Daytime Cold and Flu Relief a controlled substance?

Daytime Cold and Flu Relief is not classified as a controlled substance by the DEA.

What is the generic name for Daytime Cold and Flu Relief?

The generic name for Daytime Cold and Flu Relief is ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl.

What is the NDC code for Daytime Cold and Flu Relief 325 mg/1?

The NDC (National Drug Code) for Daytime Cold and Flu Relief 325 mg/1 is 57243-604, listed by SALADO SALES INC..

Product NDC

57243-604

Package NDC

57243-604-03

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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)