Cold Preparation For Cough and Sinus Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Cold Preparation For Cough and Sinus Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM

Mfr: OTC
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Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients citric acid FD&C yellow #6 flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol sucralose xanthan gum
Strengths
15 ml 325 mg 10 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold Flu Symptoms Minor Aches And Pains Headache Sore Throat Fever Nasal Congestion Cough Due To Minor Throat And Bronchial Irritation

Identifiers & Packaging

Container Type UNKNOWN
Packaging

Principal Display Panel *Compare to active ingredients in Vicks® DayQuil® Cold Preparation Acetaminophen Pain reliever/fever reducer Dextromethorphan hBr Cough suppressant Phenylephrine HCl Nasal decongestant For cough and sinus relief For ages 6 and over FL OZ (mL) TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. Distributed by: New Genesis/Monticello Drug LLC Jacksonville, FL 32207; Package Label Monticello Cold Preparation Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Package Descriptions
  • Principal Display Panel *Compare to active ingredients in Vicks® DayQuil® Cold Preparation Acetaminophen Pain reliever/fever reducer Dextromethorphan hBr Cough suppressant Phenylephrine HCl Nasal decongestant For cough and sinus relief For ages 6 and over FL OZ (mL) TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. Distributed by: New Genesis/Monticello Drug LLC Jacksonville, FL 32207
  • Package Label Monticello Cold Preparation Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Overview

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Dosage & Administration

Directions do not take more than directed (see overdose warning) do not exceed 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter age dose adults and children 12 years and over 30 mL every 4 hours children 6 to 11 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses (180 mL) in 24 hours for adults more than 5 doses ( 75 mL) in 24 hours for children 6-12 years old with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allery 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if the user has liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage . Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant

Do Not Use

Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

When Using

When using this product, do not exceed recommended dosage .

Stop Use & Ask a Doctor

Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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? Call us at 904-647-7825 or online at www.newgenesismonticellodrug.com


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