Drug Facts
Composition & Profile
Identifiers & Packaging
Principal display panel LEADER♥ ™ NDC 70000-0525-1 Severe Cold & Flu Acetaminophen | Dextromethorphan HBr Guaifenesin | Phenylephrine HCl Pain Reliever / Fever Reducer | Cough Suppressant Expectorant | Nasal Decongestant Headache, Fever, Sore Throat, Nasal Congestion, Cough, Mucus, Chest Congestion 24 CAPLETS Actual Size COMPARE TO TYLENOL ® COLD + FLU SEVERE active ingredients † 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol ® COLD + FLU SEVERE. 50844 REV0922A50308 DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 ©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. ✓ 100% Money Back Guarantee Return to place of purchase. CIN 5564372 REV.2/23 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Leader 44-503A Leader 44-503A
- Principal display panel LEADER♥ ™ NDC 70000-0525-1 Severe Cold & Flu Acetaminophen | Dextromethorphan HBr Guaifenesin | Phenylephrine HCl Pain Reliever / Fever Reducer | Cough Suppressant Expectorant | Nasal Decongestant Headache, Fever, Sore Throat, Nasal Congestion, Cough, Mucus, Chest Congestion 24 CAPLETS Actual Size COMPARE TO TYLENOL ® COLD + FLU SEVERE active ingredients † 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol ® COLD + FLU SEVERE. 50844 REV0922A50308 DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 ©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. ✓ 100% Money Back Guarantee Return to place of purchase. CIN 5564372 REV.2/23 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Leader 44-503A Leader 44-503A
Overview
Uses temporarily relieves these common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Indications & Usage
Uses temporarily relieves these common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Dosage & Administration
Directions do not take more than directed 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. 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 or any of its ingredients Ask a doctor before use if you have heart disease liver disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if 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 cough comes back or occurs with rash or headache that lasts. 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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/fever reducer Cough suppressant Expectorant 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. if you have ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product do not exceed recommended dosage.
Stop Use & Ask a Doctor
Stop use and ask a doctor if 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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Questions
Questions or comments? 1-800-426-9391
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