Complete SPL Sections
Active ingredients (in each 20 mL)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg
Purposes
OTC - PURPOSE SECTION
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
INDICATIONS & USAGE SECTION
• temporarily relieves these symptoms occurring with a cold or flu: • cough due to minor throat and bronchial irritation • nasal congestion • sinus congestion and pressure • minor aches and pains • sore throat • headache • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Warnings
WARNINGS SECTION
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.
Directions
DOSAGE & ADMINISTRATION SECTION
• do not take more than 5 doses in any 24-hour period • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use
Other information
STORAGE AND HANDLING SECTION
• each 20 mL contains: sodium 14 mg • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
INACTIVE INGREDIENT SECTION
anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions or comments?
OTC - QUESTIONS SECTION
1-800-719-9260
Package/Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Leader ™ Adult | Maximum Strength Tussin CF Severe Multi-Symptom Cough Cold + Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant Raspberry Flavor Ages 12 Years and Over Relieves: Cough, Sore Throat, Body Aches, Fever, Nasal Congestion, Chest Congestion Non-Drowsy COMPARE TO ROBITUSSIN ® SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients 100% Money Back Guarantee 4 FL OZ (118 mL)