Severe Cold and Flu Night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN SODIUM PHOSPHATE, MONOBASIC POLYETHYLENE GLYCOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SUCROSE XANTHAN GUM clear, dark
Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel COMPARE TO the Active Ingredients of Vicks® NyQuil® Severe See New Warnings Maximum Strength Severe Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate – Antihistamine Phenylephrine HCl – Nasal Decongestant Nighttime Berry Flavor Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough ALCOHOL FREE 8 FL OZ (237 mL) Severe Cold and Flu Image 1 Severe Cold and Flu Image 2
- Package/Label Principal Display Panel COMPARE TO the Active Ingredients of Vicks® NyQuil® Severe See New Warnings Maximum Strength Severe Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate – Antihistamine Phenylephrine HCl – Nasal Decongestant Nighttime Berry Flavor Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough ALCOHOL FREE 8 FL OZ (237 mL) Severe Cold and Flu Image 1 Severe Cold and Flu Image 2
Overview
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose
Indications & Usage
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose
Dosage & Administration
Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use Other information • each 30 mL contains: sodium 12 mg • store at 20°-25°C (68°-77°F)
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 • 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough 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 use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough 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 rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine 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. • if you have ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough 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 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). 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 30 mL contains: sodium 12 mg • store at 20°-25°C (68°-77°F)
Questions
Questions or comments? 1-800-719-9260
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