Nuvicare Daytime And Nighttime Cold And Flu Kit
FDA Label NDC 84324-025

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Nuvicare Daytime And Nighttime Cold And Flu (NDC 84324-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses:, warning, do not use:, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)- Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerol, Sorbitol sorbitan solution,FD&C Red No. 40, FD&C Yellow No. 6.

(Nighttime)- Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerin, Sorbitol sorbitan solution,D&C Yellow No. 10, FD&C Blue No. 1.

* Please review the disclaimer below.