Theraflu Warming Relief Daytime Severe Cold And Cough Acetaminophen, Dextromethorphan HBr, Phenylepherine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel NDC 0043-0461-08 Theraflu Warming Relief ® Daytime SEVERE COLD & COUGH ACETAMINOPHEN - PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever Cherry Flavor Alcohol content: 10% 8.3 FL OZ (245.5 mL) PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org 2007539 T/F WR DT front PDP
- Principal Display Panel NDC 0043-0461-08 Theraflu Warming Relief ® Daytime SEVERE COLD & COUGH ACETAMINOPHEN - PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever Cherry Flavor Alcohol content: 10% 8.3 FL OZ (245.5 mL) PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org 2007539 T/F WR DT front PDP
Overview
Uses • temporarily relieves • minor aches and pains • headache • minor sore throat pain • nasal congestion • cough due to minor throat and bronchial irritation as may occur with a cold • temporarily reduces fever
Indications & Usage
Uses • temporarily relieves • minor aches and pains • headache • minor sore throat pain • nasal congestion • cough due to minor throat and bronchial irritation as may occur with a cold • temporarily reduces fever
Dosage & Administration
Directions • do not use more than directed • take every 4 hours, in dose cup provided, while symptoms persist • do not take more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours 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 2 tablespoonfuls (30 mL)
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours, which is the maximum daily amount • 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 • 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 • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic 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 occurs • pain, cough or nasal congestion 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 a fever, rash or headache that lasts. These could be signs of a serious condition If pregnant or breast-feeding, ask a health 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
Purpose Pain reliever/fever reducer Cough suppressant 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 • 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 • nervousness, dizziness, or sleeplessness occurs • pain, cough or nasal congestion 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 a 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 tablespoonful (15 mL) contains: sodium 8 mg • store at controlled room temperature 20-25C (68-77F)
Questions
Questions or Comments? call 1-800-452-0051
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