MAXIMUM STRENGTH Sinus Relief ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE DOXYLAMINE SUCCINATE TOPCO ASSOCIATES LLC FDA Approved Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily 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. Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing • temporarily promotes nasal and/or sinus drainage
FunFoxMeds box
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each softgel) DAY Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) NIGHT Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients edible printing ink FD&C Blue no. 1 FD&C Red no. 40 gelatin glycerin polyethylene glycol 400 povidone K30 propylene glycol purified water sorbitol sorbitan solution Inactive ingredients edible printing ink FD&C Blue no. 1 gelatin glycerin polyethylene glycol 400 povidone K30 propylene glycol purified water sorbitol sorbitan solution
Strengths
325 mg 10 mg 200 mg 5 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves Nasal Congestion Headache Cough Minor Aches Pains Sinus Congestion Pressure Temporarily 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 Uses Temporarily Relieves Nasal Congestion Headache Cough Minor Aches Pains Sinus Congestion Pressure Runny Nose And Sneezing Temporarily Promotes Nasal And Or Sinus Drainage

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
Packaging

Packaging Topco-824

Package Descriptions
  • Packaging Topco-824

Overview

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily 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. Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing • temporarily promotes nasal and/or sinus drainage

Indications & Usage

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily 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. Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing • temporarily promotes nasal and/or sinus drainage

Dosage & Administration

Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these 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. 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. Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin When using these products • do not use more than directed. Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • 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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products 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. 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. Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using these products • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • 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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purposes Pain reliever Cough suppressant Expectorant Nasal decongestant Purposes Pain reliever Cough suppressant Antihistamine Nasal decongestant

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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture

Questions

Questions or comments? Call: 1-888-423-0139 Questions or comments? Call: 1-888-423-0139


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