FDA Label for Nuvicare Daytime And Nighttime Cold And Flu
View Indications, Usage & Precautions
Nuvicare Daytime And Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Nuvicare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredients
Active ingredients in DayTime (in each softgel)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Active ingredients in NightTime (in each softgel)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine Succinate 6.25 mg
Purpose
DayTime
Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant
NightTime
Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 15mg..................... Cough suppressant
Doxylamine succinate 6.25 mg ............................. Antihistamine
Uses:
temporarily relieves common cold/flu symptoms:
■ nasal congestion (DayTime Only)
■ cough due to minor throat & bronchial irritation
■ sore throat
■ headache
■ minor aches & pains
■ fever
■ Runny nose and sneezing (NightTime only)
Warning
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4 doses in 24 hrs, 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: acetamenophen may cause severe skin recations. Symptoms may include:
■ skin reddening ■ blisters ■ rash. if a skin reactions 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.
- to make a child sleep (NightTime Only).
Directions
■ take only as directed- see OVERDOSE WARNING
■ do not exceed 8 softgels per 24 hrs.
■ Take softgels with water
DayTime | NightTime | |
Adults and children age 12 yrs and over | 2 softgels every 4 hrs. | 2 softgels every 6 hrs. |
Children 4 to under 12 yrs | ask a doctor | ask a doctor |
Children under 4 yrs | do not use | do not use |
Read each label carefully before taking Daytime and Nighttime products.
Other Information
■ store between 15-30°C (59-86 °F)
■ avoid excessive heat, cold and humidity
Inactive Ingredients
(Daytime) FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Polyethylene glycol-400, Povidone (PVPK-30), Propylene glycol,
Purified water, Sorbitol sorbitan solution
(Nighttime) D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Polyethylene glycol-400, Povidone (PVPK-30), Propylene glycol, Purified water, Sorbitol sorbitan solution
Questions Or Comments?
Call 1 (718) 337-8733 or email: [email protected]
* Please review the disclaimer below.
