Drugplain

Daytime Cold and Flu 325 mg/1

Acetaminophen and Dextromethorphan hydrobromide · CAPSULE, LIQUID FILLED · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd

No Recall HistoryCurrently in Shortage
Plain English

Daytime Cold And Flu is an over-the-counter medicine in capsule form that contains acetaminophen to reduce fever and pain, and dextromethorphan to suppress coughs associated with colds and the flu. Each dose contains 325 mg of acetaminophen and 1 mg of dextromethorphan hydrobromide.

Key Facts

Brand Name
Daytime Cold and Flu
Generic Name
Acetaminophen and Dextromethorphan hydrobromide
NDC Code (Product)
53345-056
Manufacturer
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/28/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea10 reports
drug ineffective9 reports
erythema9 reports
headache9 reports
malaise9 reports
weight decreased9 reports
off label use8 reports
abdominal pain7 reports
anaemia7 reports
chronic sinusitis7 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: 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 inclide: 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes hig…

Frequently Asked Questions

What is Daytime Cold and Flu used for?

Daytime Cold And Flu is an over-the-counter medicine in capsule form that contains acetaminophen to reduce fever and pain, and dextromethorphan to suppress coughs associated with colds and the flu. Each dose contains 325 mg of acetaminophen and 1 mg of dextromethorphan hydrobromide.

Is Daytime Cold and Flu a controlled substance?

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

What is the generic name for Daytime Cold and Flu?

The generic name for Daytime Cold and Flu is Acetaminophen and Dextromethorphan hydrobromide. There are 7 other brand versions of Acetaminophen and Dextromethorphan hydrobromide.

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

The NDC (National Drug Code) for Daytime Cold and Flu 325 mg/1 is 53345-056, listed by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.

Product NDC

53345-056

Package NDC

53345-056-01

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)