Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 6 Packet Carton See new warnings information & directions NDC 11673-113-07 Compare to active ingredients in Theraflu ® Nighttime Severe Cold & Cough* nighttime severe cold, cough and flu 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 honey lemon infused with chamomile and white tea flavors up & up HONEY LEMON FLAVOR 6 PACKETS 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton
- PRINCIPAL DISPLAY PANEL - 6 Packet Carton See new warnings information & directions NDC 11673-113-07 Compare to active ingredients in Theraflu ® Nighttime Severe Cold & Cough* nighttime severe cold, cough and flu 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 honey lemon infused with chamomile and white tea flavors up & up HONEY LEMON FLAVOR 6 PACKETS 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton
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 take every 4 hours; do not take more than 5 packets in 24 hours unless 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 & Precautions
Warnings 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. 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. Do not use 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 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 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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 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. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care 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
Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant
Do Not Use
Do not use 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 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 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. 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 packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
Questions
Questions or Comments? Call 1-800-910-6874
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