Principal Display
6c133d12-773e-466e-aaea-d165a7d1df81
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
Medication Information
Warnings and Precautions
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 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.
Indications and Usage
▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
Dosage and Administration
▪ do not use more than directed ▪ take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
Description
Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
Section 42229-5
LEADER NDC 70000-0128-1 Nighttime Severe Cold & Cough Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain reliever/ Fever reducer Antihistamine/ Cough suppressant Nasal Decongestant Honey Lemon Infused with Chamomile & White Tea Flavors Naturally and Artificially Flavored COMPARE TO THERAFLU ® NIGHTTIME SEVERE COLD & COUGH* active ingredients * 100% Money Back Guarantee Relieves: Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache & Fever 6 PACKETS READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD, NIGHTTIME Severe Cough & Cold Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to care™ since 1979 TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. ©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu ® Nighttime Severe Cold & Cough.
Section 44425-7
▪ each packet contains: potassium 6 mg ▪ store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect from excessive heat and moisture.
Section 50565-1
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9
▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ symptoms do not get better or worsen ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
Section 50567-7
▪ do not exceed recommended dosage ▪ avoid alcoholic drinks ▪ marked drowsiness may occur ▪ alcohol, sedatives and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children
Section 50568-5
▪ sedatives or tranquilizers ▪ the blood thinning drug warfarin
Section 50569-3
▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ a sodium-restricted diet ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema, asthma or chronic bronchitis ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1
▪ in a child under 4 years of age ▪ if you are allergic to acetaminophen ▪ 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 the 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 a MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6
citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6
Section 51945-4
Nighttime Severe Cold & Cough Honey lemon 6 packets
Section 53413-1
1-866-467-2748
Section 53414-9
ask a health care professional before use.
Section 55105-1
Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant
Section 55106-9
Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
Structured Label Content
Indications and Usage (34067-9)
▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
Dosage and Administration (34068-7)
▪ do not use more than directed ▪ take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
Warnings and Precautions (34071-1)
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 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.
Section 42229-5 (42229-5)
LEADER NDC 70000-0128-1 Nighttime Severe Cold & Cough Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain reliever/ Fever reducer Antihistamine/ Cough suppressant Nasal Decongestant Honey Lemon Infused with Chamomile & White Tea Flavors Naturally and Artificially Flavored COMPARE TO THERAFLU ® NIGHTTIME SEVERE COLD & COUGH* active ingredients * 100% Money Back Guarantee Relieves: Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache & Fever 6 PACKETS READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD, NIGHTTIME Severe Cough & Cold Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to care™ since 1979 TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. ©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu ® Nighttime Severe Cold & Cough.
Section 44425-7 (44425-7)
▪ each packet contains: potassium 6 mg ▪ store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect from excessive heat and moisture.
Section 50565-1 (50565-1)
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ symptoms do not get better or worsen ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
Section 50567-7 (50567-7)
▪ do not exceed recommended dosage ▪ avoid alcoholic drinks ▪ marked drowsiness may occur ▪ alcohol, sedatives and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children
Section 50568-5 (50568-5)
▪ sedatives or tranquilizers ▪ the blood thinning drug warfarin
Section 50569-3 (50569-3)
▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ a sodium-restricted diet ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema, asthma or chronic bronchitis ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1 (50570-1)
▪ in a child under 4 years of age ▪ if you are allergic to acetaminophen ▪ 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 the 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 a MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6 (51727-6)
citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6
Section 51945-4 (51945-4)
Nighttime Severe Cold & Cough Honey lemon 6 packets
Section 53413-1 (53413-1)
1-866-467-2748
Section 53414-9 (53414-9)
ask a health care professional before use.
Section 55105-1 (55105-1)
Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant
Section 55106-9 (55106-9)
Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
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Source: dailymed · Ingested: 2026-02-15T11:59:22.234579 · Updated: 2026-02-15T11:59:22.218025