leader flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME SILICON DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE
Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel Compare to Theraflu® Severe Cold & Cough active ingredients Flu & Severe Cold & Cough Daytime Pain Reliever – Fever Reducer (Acetaminophen) Cough Suppressant (Dextromethorphan HBr) Nasal Decongestant (Phenylephrine HCl) NASAL & SINUS CONGESTION COUGH BODY ACHE SORE THROAT PAIN HEADACHE FEVER Berry Infused with Menthol & Green Tea Flavors Flu & Severe Cold & Cough Carton
- Package/Label Principal Display Panel Compare to Theraflu® Severe Cold & Cough active ingredients Flu & Severe Cold & Cough Daytime Pain Reliever – Fever Reducer (Acetaminophen) Cough Suppressant (Dextromethorphan HBr) Nasal Decongestant (Phenylephrine HCl) NASAL & SINUS CONGESTION COUGH BODY ACHE SORE THROAT PAIN HEADACHE FEVER Berry Infused with Menthol & Green Tea Flavors Flu & Severe Cold & Cough Carton
Overview
Uses • temporarily relieves • minor aches and pains • minor sore throat • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever
Indications & Usage
Uses • temporarily relieves • minor aches and pains • minor sore throat • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever
Dosage & Administration
Directions • do not use more than directed – see Liver warning • take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor • adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. • children under 12 years of age: consult a doctor • 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 6 packets in 24 hours, which is the maximum daily amount for this product • 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 • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet 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 • you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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 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. (1-800-222-1222) Quick 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 Cough suppressant 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.
When Using
When using this product • do not exceed recommended dosage
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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. (1-800-222-1222) Quick 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 5 mg and sodium 41 mg • phenylketonurics: contains phenylalanine 17 mg per packet • store at 20°-25°C (68°-77°F)
Questions
Questions or comments? 1-800-719-9260
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