Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel Nighttime Compare to Theraflu ® Nighttime Severe Cold & Cough active ingredients Multi-Symptom Severe Cold & Cough Acetaminophen – Pain Reliever/Fever Reducer Diphenhydramine HCl – Antihistamine/Cough Suppressant Phenylephrine HCl – Nasal Decongestant - Nasal Congestion - Cough - Runny Nose - Sneezing - Body Ache - Sore Throat Pain - Headache/Fever 6 PACKETS Honey Lemon Infused with White Tea Flavors severe cold and cough image
- Package/Label Principal Display Panel Nighttime Compare to Theraflu ® Nighttime Severe Cold & Cough active ingredients Multi-Symptom Severe Cold & Cough Acetaminophen – Pain Reliever/Fever Reducer Diphenhydramine HCl – Antihistamine/Cough Suppressant Phenylephrine HCl – Nasal Decongestant - Nasal Congestion - Cough - Runny Nose - Sneezing - Body Ache - Sore Throat Pain - Headache/Fever 6 PACKETS Honey Lemon Infused with White Tea Flavors severe cold and cough image
Overview
Uses • 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
Indications & Usage
Uses • 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 & Administration
Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • 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 & 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 • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema 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 Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • 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 Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • redness or swelling is present • fever gets worse or lasts more than 3 days • pain, cough or nasal congestion gets worse or lasts more than 7 days • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.
Purpose
Purposes Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Do Not Use
Do not use • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • 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.
When Using
When using this product • 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
Stop Use & Ask a Doctor
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • redness or swelling is present • fever gets worse or lasts more than 3 days • pain, cough or nasal congestion gets worse or lasts more than 7 days • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.
Storage & Handling
Other information • each packet contains: potassium 10 mg and sodium 25 mg • phenylketonurics: contains phenylalanine 13 mg per packet • store at 20-25 ° C (68-77 ° F). Protect product from heat and moisture.
Questions
Questions or comments? 1-800-719-9260
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