Nuvicare Nighttime Cold And Flu Softgel Capsule, Liquid Filled
FDA Label NDC 84324-024

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 Nighttime Cold And Flu Softgel (NDC 84324-024). 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 (in each softgel), 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 (In Each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 15mg..................... Cough suppressant
Doxylamine succinate 6.25 mg ............................. Antihistamine

Uses:

temporarily relieves these common cold/flu symptoms:
■ minor aches & pains

■ headache

■ sore throat

■ fever

■ Runny nose and sneezing

■ cough due to minor throat & bronchial irritation

Warning

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 8 softgels in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday 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:

  • 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 

Directions

■ take only as directed- see OVERDOSE WARNING

■ do not exceed 8 softgels per 24 hrs. 

■ take softgels with water

 Adults and children age 12 yrs and over2 softgels every 6 hrs. 
 Children 4 to under 12 yrs  ask a doctor
 Children under 4 yrs do not use

Other Information

■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat

Inactive Ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone K-30,Purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution, FD & C Blue No. 1, D &C Yellow No.10

* Please review the disclaimer below.