SEVERE COLD PLUS FLU DAYTIME NIGHTTIME ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE AND DOXYLAMINE SUCCINATE CVS PHARMACY,INC. FDA Approved Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever Uses temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever
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Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each packet) Purposes Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine hydrochloride 10 mg Nasal decongestant Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine Phenylephrine hydrochloride 10 mg Nasal decongestant
Inactive Ingredients
Inactive ingredients anhydrous citric acid flavors maltodextrin potassium citrate silica sucralose sucrose yellow#6 Inactive ingredients anhydrous citric acid flavors maltodextrin potassium citrate silica sucralose sucrose yellow#6
Strengths
500 mg 20 mg 400 mg 10 mg 650 mg 12.5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Or Flu Minor Aches And Pains Headache Sore Throat Cough Nasal Congestion Sinus Congestion And Pressure Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus Temporarily Reduces Fever Uses Temporarily Relieves These Symptoms Due To A Cold Or Flu Headache Minor Aches And Pains Cough Sore Throat Nasal Congestion Sinus Congestion And Pressure Runny Nose Sneezing Temporarily Reduces Fever

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
Packaging

PRINCIPAL DISPLAY PANEL- C ompare to Alka-Seltzer PLUS ® Severe Cold +Flu Day and Night Active Ingredients* DAYTIME SEVERE COLD & FLU Acetaminophen / Pain reliever-fever reducer Dextromethorphan HBr / Cough suppressant Guaifenesin / Expectorant Phenylephrine HCl / Nasal decongestant Relieves: • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Mucus • Chest Congestion • Fever Honey Lemon Flavor Naturally and Artificially Flavored NIGHTTIME Severe Cold & Flu Acetaminophen / Pain reliever-fever reducer Dextromethorphan HBr / Cough suppressant Doxylamine succinate / Antihistamine Phenylephrine HCl / Nasal decongestant Relieves: • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Runny Nose • Fever Honey Lemon Flavor Naturally and Artificially Flavored TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN DO NOT TAKE THESE PRODUCTS AT THE SAME TIME 6 DAY PACKETS + 6 NIGHT PACKETS 12 TOTAL Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 ©2017 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Money Back Guarantee *These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night. Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor

Package Descriptions
  • PRINCIPAL DISPLAY PANEL- C ompare to Alka-Seltzer PLUS ® Severe Cold +Flu Day and Night Active Ingredients* DAYTIME SEVERE COLD & FLU Acetaminophen / Pain reliever-fever reducer Dextromethorphan HBr / Cough suppressant Guaifenesin / Expectorant Phenylephrine HCl / Nasal decongestant Relieves: • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Mucus • Chest Congestion • Fever Honey Lemon Flavor Naturally and Artificially Flavored NIGHTTIME Severe Cold & Flu Acetaminophen / Pain reliever-fever reducer Dextromethorphan HBr / Cough suppressant Doxylamine succinate / Antihistamine Phenylephrine HCl / Nasal decongestant Relieves: • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Runny Nose • Fever Honey Lemon Flavor Naturally and Artificially Flavored TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN DO NOT TAKE THESE PRODUCTS AT THE SAME TIME 6 DAY PACKETS + 6 NIGHT PACKETS 12 TOTAL Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 ©2017 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Money Back Guarantee *These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night. Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor

Overview

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever Uses temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever Uses temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor adults and children 12 years 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: do not use Directions do not take more than the recommended dose take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor adults and children 12 years 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: do not use

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 ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. Skin reddening Blisters Rash Hives facial swelling asthma(wheezing) shock Is a skin or general allergic 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 in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough with excessive phlegm (mucus) 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 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 rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 at 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 you take more than 5 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 ALLERGY ALERT Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash Hives facial swelling asthma (wheezing) shock Is a skin or general allergic 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 to sedate children. 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 in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the 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 the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if 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 rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 at 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.
Adverse Reactions

ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. Skin reddening Blisters Rash Hives facial swelling asthma(wheezing) shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ALLERGY ALERT Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash Hives facial swelling asthma (wheezing) shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away

Purpose

Active ingredients (in each packet) Purposes Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine hydrochloride 10 mg Nasal decongestant Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine Phenylephrine hydrochloride 10 mg 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 in children under 12 years of age 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 in children under 12 years of age

When Using

When using this product do not exceed recommended dosage When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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 rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs Stop use and ask a doctor if 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 rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs

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 at 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. In case of overdose, get medical help or contact a Poison Control Center right away at 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 6 mg store at room temperature Other information each packet contains: potassium 6 mg store at room temperature

Questions

Questions or comments? 1-866-467-2748 Questions or comments? 1-866-467-2748


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