Leader Daytime Severe Cold and Flu 325 mg/15mL

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl · SOLUTION · Cardinal Health 110, LLC. dba Leader

No Recall HistoryCurrently in Shortage

Plain English

Leader Daytime Severe Cold and Flu is a solution containing acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl at 325 mg/15mL, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name: Leader Daytime Severe Cold and Flu
Generic Name: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
NDC Code (Product): 70000-0192
Manufacturer: Cardinal Health 110, LLC. dba Leader
Strength: 325 mg/15mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 11/23/2016

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 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.

Frequently Asked Questions

What is Leader Daytime Severe Cold and Flu used for?

Leader Daytime Severe Cold and Flu contains acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl. It is a solution taken oral. Consult your doctor for specific uses.

Is Leader Daytime Severe Cold and Flu a controlled substance?

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

What is the generic name for Leader Daytime Severe Cold and Flu?

The generic name for Leader 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 Leader Daytime Severe Cold and Flu 325 mg/15mL?

The NDC (National Drug Code) for Leader Daytime Severe Cold and Flu 325 mg/15mL is 70000-0192, listed by Cardinal Health 110, LLC. dba Leader.

Product NDC

70000-0192

Package NDC

70000-0192-1

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)