Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF Nite Time Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr ANTIHISTAMINE – DOXYLAMINE SUCCINATE • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough 12 FL OZ (355 mL) HONEY FLAVOR 86s-88-nite-time-cold-and-flu
- Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF Nite Time Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr ANTIHISTAMINE – DOXYLAMINE SUCCINATE • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough 12 FL OZ (355 mL) HONEY FLAVOR 86s-88-nite-time-cold-and-flu
Overview
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
Indications & Usage
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
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 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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. • to make a child sleepy • 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 • glaucoma • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers 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 5 days (children) or 7 days (adults) • 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. 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.
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. • to make a child sleepy • 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 5 days (children) or 7 days (adults) • 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.
Questions
Questions? 1-888-423-0139
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