Leader Vapor Ice Cold and Flu 325 mg/1

acetaminophen, dextromethorphan hydrobromide · TABLET, FILM COATED · Cardinal Health 110, LLC. dba Leader

No Recall HistoryCurrently in Shortage

Plain English

Leader Vapor Ice Cold and Flu is a tablet, film coated containing acetaminophen, dextromethorphan hydrobromide at 325 mg/1, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name: Leader Vapor Ice Cold and Flu
Generic Name: acetaminophen, dextromethorphan hydrobromide
NDC Code (Product): 70000-0747
Manufacturer: Cardinal Health 110, LLC. dba Leader
Strength: 325 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 01/14/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

asthenopia1 reports

epistaxis1 reports

feeling abnormal1 reports

incorrect dose administered1 reports

poor quality product administered1 reports

product complaint1 reports

somnolence1 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 Leader Vapor Ice Cold and Flu used for?

Leader Vapor Ice Cold and Flu contains acetaminophen, dextromethorphan hydrobromide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Leader Vapor Ice Cold and Flu a controlled substance?

Leader Vapor Ice Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for Leader Vapor Ice Cold and Flu?

The generic name for Leader Vapor Ice Cold and Flu is acetaminophen, dextromethorphan hydrobromide. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide.

What is the NDC code for Leader Vapor Ice Cold and Flu 325 mg/1?

The NDC (National Drug Code) for Leader Vapor Ice Cold and Flu 325 mg/1 is 70000-0747, listed by Cardinal Health 110, LLC. dba Leader.

Product NDC

70000-0747

Package NDC

70000-0747-1

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)