Fibrocane Calm
FDA Label NDC 57850-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Bioceuticals Llc. for the product Fibrocane Calm (NDC 57850-0001). 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 indications & usage, otc - active ingredient, inactive ingredient, dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.

Otc - Active Ingredient

Active Ingredients: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient at 10X, 30X, LM1 potencies.

Inactive Ingredient

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Dosage & Administration

Directions: Initially, depress pump until primed. Hold close and spray directly into your mouth. Take 2 pump sprays twice daily, morning and evening. Additional sprays may be taken during the night as needed. For ages 12 and above.

Warnings

Warnings

  • Stop use and call a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, consult a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Other Safety Information

Other Information:

Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Purpose

FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:

  • restlessness
  • nervousness
  • exhaustion
  • excitability
  • worry or inability to fall or stay asleep

Package Label.Principal Display Panel

Image Description (Fibrocane)

Image Description (Fibrocane)

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