Flunada
FDA Label NDC 54705-160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Flutrends International Corporation for the product Flunada (NDC 54705-160). 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 active ingredients: (in each 20 ml), purpose, description, uses:, warnings:, directions:, inactive ingredients:, for questions / comments:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients: (In Each 20 Ml)

Eucalyptol 3x HPUS

Eucalyptus globulus 3x HPUS

Gaultheria 3x HPUS

Mentholum 4x HPUS

Sambucus nigra 2x HPUS

Purpose

  • Stuffed up nose, watery nose
  • Sore throat, runny or stuffed nose, headache
  • Aches and/or pains
  • Post nasal drip, runny nose, headache, sore throat
  • Blocked or stuffy nose, cough

Description

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Uses:

For relief of cold and flu-like symptoms such as nasal congestion, runny or blocked nose, post nasal drip, sore throat, cough and headache. For optimal results, use at first sign of cold or flu-like symptoms.

Warnings:

  • Do not use if pump bottle seal is broken.
  • Use of this dispenser by more than one person can spread infection.
  • Ask a doctor before use if you have asthma or known allergies to any product ingredient, or a history of nose bleeds.
  • Consult a healthcare professional if you are pregnant or breast-feeding.
  • Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
  • Ask a doctor before use in children younger than 4 years of age.
  • Keep out of reach of children.

Directions:

  • Adults and children 4 years and older. Spray 3 times to throat and swallow; also spray once into each nostril, let drip, then swallow.
  • Use up to 4 times daily, up to 5 days.
  • Store at room temperature in a cool, dry place.

Inactive Ingredients:

Citric acid, ethanol, glycerin, poloxamer 407, sodium benzoate, sodium chloride, sorbitol, thymol, water, xylitol.

For Questions / Comments:

call (888) 407-2816

www.flunada.com

Image Of 20Ml Carton And Label

FluNadaCarton2014.jpg

Carton (Flunadacarton2014)

Carton (Flunadacarton2014)

 FluNadaLabel2014.jpg
Label (Flunadalabel2014)

Label (Flunadalabel2014)

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