Cold Preparation For Cough and Sinus Relief
Medically reviewed on January 5, 2018
Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: New Genesis/Monticello Drug LLC
NDC Code: 11868-466
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Pain reliever/fever reducer
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- cough due to minor throat and bronchial irritation
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
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.
- 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.
- liver disease
- heart disease
- thyroid disease
- 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
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- 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.
ask a health professional before use.
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.
- 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
|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
- each 15 mL contains: sodium 12 mg
- store between 20-25ºC (68-77ºF)
- do not refrigerate
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Call us at 904-647-7825 or online at www.newgenesismonticellodrug.com
*Compare to active ingredients in Vicks® DayQuil®
Pain reliever/fever reducer
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
FOR COUGH AND SINUS RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
|Labeler - New Genesis/Monticello Drug LLC (079396165)|