TOPCARE HONEY FLAVOR COLD AND FLU RELIEF ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE TOPCO ASSOCIATES LLC FDA Approved 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 Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid D&C yellow #10 edetate disodium FD&C green #3 FD&C red #40 FD&C yellow #6 flavor glycerin polyethylene glycol propylene glycol purified water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol solution sucralose xanthan gum Inactive ingredients anhydrous citric acid D&C yellow #10 edetate disodium FD&C green #3 FD&C red #40 FD&C yellow #6 flavor glycerin polyethylene glycol propylene glycol purified water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol solution sucralose xanthan gum
Strengths
15 ml 325 mg 10 mg 6.25 mg 5 mg 200 mg
Quantities
2 bottles 355 ml 710 ml
Treats Conditions
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 Uses Temporarily Relieves Common Cold Flu Symptoms Nasal Congestion Sinus Congestion And Pressure Cough Due To Minor Throat And Bronchial Irritation Minor Aches And Pains Headache Fever Sore Throat Reduces Swelling Of Nasal Passages Temporarily Restores Freer Breathing Through The Nose Promotes Nasal And Or Sinus Drainage Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
Packaging

Package/Label Principal Display Panel TopCare® health COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR and VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS Honey Flavor Cold & Flu Relief DAY & NIGHT COMBO PACK TopCare ® health COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF DayTime Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr EXPECTORANT - GUAIFENESIN • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Thins & Loosens Mucus • Chest Congestion • Cough Non-Drowsy TopCare ® health COMPARE TO VICKS® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF NiteTime Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl ANTIHISTAMINE – DOXYLAMINE SUCCINATE COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough HONEY FLAVOR POWERFUL RELIEF DAY OR NIGHT 2 BOTTLES – 1 DAYTIME/1 NIGHTTIME 12 FL OZ (355 mL) EACH; TOTAL 24 FL OZ (1.5 pt) (710 mL) topcare-honey-flavor-cold-&-flu-relief-carton-image-1.jpg topcare-honey-flavor-cold-&-flu-relief-carton-image-2.jpg

Package Descriptions
  • Package/Label Principal Display Panel TopCare® health COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR and VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS Honey Flavor Cold & Flu Relief DAY & NIGHT COMBO PACK TopCare ® health COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF DayTime Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr EXPECTORANT - GUAIFENESIN • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Thins & Loosens Mucus • Chest Congestion • Cough Non-Drowsy TopCare ® health COMPARE TO VICKS® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS MAXIMUM STRENGTH RELIEF NiteTime Cold & Flu SEVERE PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN NASAL DECONGESTANT – PHENYLEPHRINE HCl ANTIHISTAMINE – DOXYLAMINE SUCCINATE COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough HONEY FLAVOR POWERFUL RELIEF DAY OR NIGHT 2 BOTTLES – 1 DAYTIME/1 NIGHTTIME 12 FL OZ (355 mL) EACH; TOTAL 24 FL OZ (1.5 pt) (710 mL) topcare-honey-flavor-cold-&-flu-relief-carton-image-1.jpg topcare-honey-flavor-cold-&-flu-relief-carton-image-2.jpg

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 Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 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 pharmacists 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. 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 emotion 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 • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough 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 use more than directed 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 Purpose Pain reliever/fever reducer Cough suppressant Expectorant 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 pharmacists 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 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 emotion 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 When using this product do not use more than directed

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. 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. 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 or comments? 1-888-423-0139 Questions or comments? 1-888-423-0139


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