Severe Cold and Flu Maximum Strength, Daytime, Non-Drowsy Acetaminophen. Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE 44;640
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal display panel LEADER ™ NDC 70000-0289-1 Daytime ι Non-Drowsy Severe Cold & Flu Acetaminophen ι Dextromethorphan HBr ι Guaifenesin ι Phenylephrine HCl Pain Reliever / Fever Reducer ι Cough Suppressant ι Expectorant ι Nasal Decongestant Relief of: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal/Sinus Congestion & Sinus Pressure, Cough, Chest Congestion 12 CAPLETS Actual Size COMPARE TO VICKS ® DAYQUIL ® SEVERE COLD & FLU active ingredients* 100% Money Back Guarantee *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks ® DayQuil ® Severe Cold & Flu. 50844 REV0519B64002 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING CIN 5326152 REV. 11/21 Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 © 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respecting owners. All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Leader 44-640 Leader 44-640
- Principal display panel LEADER ™ NDC 70000-0289-1 Daytime ι Non-Drowsy Severe Cold & Flu Acetaminophen ι Dextromethorphan HBr ι Guaifenesin ι Phenylephrine HCl Pain Reliever / Fever Reducer ι Cough Suppressant ι Expectorant ι Nasal Decongestant Relief of: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal/Sinus Congestion & Sinus Pressure, Cough, Chest Congestion 12 CAPLETS Actual Size COMPARE TO VICKS ® DAYQUIL ® SEVERE COLD & FLU active ingredients* 100% Money Back Guarantee *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks ® DayQuil ® Severe Cold & Flu. 50844 REV0519B64002 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING CIN 5326152 REV. 11/21 Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 © 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respecting owners. All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Leader 44-640 Leader 44-640
Overview
Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation 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
Indications & Usage
Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation 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 do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 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: blisters rash skin reddening 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 liver disease thyroid disease diabetes heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 accidental 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 accidental 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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 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
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.