Nuvicare Daytime Cold And Flu Softgel Capsule, Liquid Filled
FDA Label NDC 84324-018

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 Cold And Flu Softgel (NDC 84324-018). 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 10mg

Phenylephrine HCl 5mg

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant

Uses:

temporarily relieves common cold/flu symptoms:
■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

Warning

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.

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 daily 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:

  • 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.

Directions

■ take only as directed- see OVERDOSE WARNING

■ do not exceed 8 softgels per 24 hrs. 

 Adults and children 12 yrs and overtake 2 softgels with water every 4 hrs. 
 Children 4 to under 12 yrs  ask a doctor
 Children under 4 yrs do not use

Other Information

■ store at room temperature between 20-25°C (68-77 °F)

■ avoid excessive heat, cold and humidity

Inactive Ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone (PVP K-30), FD & C Red No. 40, FD &C Yellow No. 6, purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution.

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