Cold Preparation Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM TRISODIUM CITRATE DIHYDRATE SUCROSE
Drug Facts
Composition & Profile
Identifiers & 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) *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING. Distributed by: Monticello Drug Company, Jacksonville, FL 32254; Package Label Monticelllo Cold Preparation Liquid Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
- 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) *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING. Distributed by: Monticello Drug Company, Jacksonville, FL 32254
- Package Label Monticelllo Cold Preparation Liquid 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 take only as recommended (see overdose warning) do not exceed 5 doses (children) or 6 doses (adults) per 24 hours use dosage cup provided tbsp=tablespoon, mL=milliliter adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours children 6 to 11 years 1 tablespoon (15 mL) every 4 hours children 4 to 5 years do not use unless directed by 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 (12 tablespoons or 180 mL) in 24 hours for adults more than 5 doses (5 tablespoons or 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 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product. 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, avoid alcoholic drinks do not use more than directed (see overdose warning) 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 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
Purpose 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product.
When Using
When using this product, avoid alcoholic drinks do not use more than directed (see overdose warning)
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 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 904-384-3666 M-Th 9AM-4PM EST or online at www.monticellodrug.com
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