Cold Head Congestion Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1--ALUMINUM LAKE CELLULOSE, MICROCRYSTALLINE TALC SUCRALOSE STARCH, CORN MAGNESIUM STEARATE TITANIUM DIOXIDE CROSPOVIDONE FD&C BLUE NO. 2--ALUMINUM LAKE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;473
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel NDC 49781-011-24 LEADER ® Compare to Tylenol ® Cold Head Congestion Nighttime active ingredients* Cold Head Congestion Nighttime Contains 4 Medicines: Pain Reliever - Acetaminophen Nasal Decongestant • Phenylephrine HCl Cough Suppressant • Dextromethorphan HBr Antihistamine • Chlorpheniramine Maleate • Headache/Sore Throat • Runny Nose • Coughing • Nasal Congestion with Cool Blast Flavor SATISFACTION GUARANTEED 24 COOL CAPLETS Actual Size *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Nighttime. 50844 ORG011347308 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 4829842 www.myleader.com 1-800-200-6313 All LEADER® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund. Leader 44-473C Leader 44-473C
- Principal Display Panel NDC 49781-011-24 LEADER ® Compare to Tylenol ® Cold Head Congestion Nighttime active ingredients* Cold Head Congestion Nighttime Contains 4 Medicines: Pain Reliever - Acetaminophen Nasal Decongestant • Phenylephrine HCl Cough Suppressant • Dextromethorphan HBr Antihistamine • Chlorpheniramine Maleate • Headache/Sore Throat • Runny Nose • Coughing • Nasal Congestion with Cool Blast Flavor SATISFACTION GUARANTEED 24 COOL CAPLETS Actual Size *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Nighttime. 50844 ORG011347308 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 4829842 www.myleader.com 1-800-200-6313 All LEADER® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund. Leader 44-473C Leader 44-473C
Overview
Uses temporarily relieves these common cold symptoms: minor aches and pains headache nasal congestion cough sneezing and runny nose sore throat sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep
Indications & Usage
Uses temporarily relieves these common cold symptoms: minor aches and pains headache nasal congestion cough sneezing and runny nose sore throat sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep
Dosage & Administration
Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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. Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma persistent or chronic cough such as occurs with smoking, asthma, or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery marked drowsiness may occur Stop use and ask a doctor if cough comes back or occurs with rash or headache that lasts nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Purpose Pain reliever Antihistamine Cough suppressant 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. 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.
When Using
When using this product do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery marked drowsiness may occur
Stop Use & Ask a Doctor
Stop use and ask a doctor if cough comes back or occurs with rash or headache that lasts nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Questions
Questions or comments? 1-800-426-9391
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