leader cold and flu Acetaminophen, diphenhydramine HCl, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POLYVINYL ALCOHOL POVIDONE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE FD&C BLUE NO. 1
Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel Multi-Symptom SEE NEW WARNINGS Compare to Mucinex® Fast-Max® Night Time Cold & Flu active ingredients For Ages 12+ MAXIMUM STRENGTH Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Diphenhydramine HCl – Antihistamine Phenylephrine HCl – Nasal Decongestant Night Time Relief Relieves Aches, Fever & Sore Throat Relieves Nasal Congestion Relieves Runny Nose & Sneezing Actual Size 20 CAPLETS Leader Cold and Flu Image 1 Leader Cold and Flu Image 2 Leader Cold and Flu Image 3
- Package/Label Principal Display Panel Multi-Symptom SEE NEW WARNINGS Compare to Mucinex® Fast-Max® Night Time Cold & Flu active ingredients For Ages 12+ MAXIMUM STRENGTH Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Diphenhydramine HCl – Antihistamine Phenylephrine HCl – Nasal Decongestant Night Time Relief Relieves Aches, Fever & Sore Throat Relieves Nasal Congestion Relieves Runny Nose & Sneezing Actual Size 20 CAPLETS Leader Cold and Flu Image 1 Leader Cold and Flu Image 2 Leader Cold and Flu Image 3
Overview
Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • headache • minor aches and pains • sore throat • runny nose and sneezing • temporarily reduces fever
Indications & Usage
Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • headache • minor aches and pains • sore throat • runny nose and sneezing • temporarily reduces fever
Dosage & Administration
Directions • do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and older: take 2 caplets every 4 hours • children under 12 years of age: do not use
Warnings & Precautions
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.
Purpose
Purposes Pain reliever/fever reducer Antihistamine Nasal decongestant
Do Not Use
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. • with any other product containing diphenhydramine, even one used on skin • 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 or any of its ingredients
When Using
When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain or nasal congestion gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Storage & Handling
Other information • store at 20-25 ° C (68-77 ° F) • do not use if blister unit is broken or torn
Questions
Questions or comments? 1-800-719-9260
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