Snore Control
FDA Label NDC 57955-5120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Snore Control (NDC 57955-5120). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients                                        Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies, except as otherwise noted.

Bromium....................................................jerking and starting during sleep

Chamomilla................................................tightness of chest

Cinchona officinalis......................................slow, labored breathing

Cuprum metallicum......................................spasms of chest

Helleborus niger...........................................irregular respiration

Laurocerasus...............................................spasmodic tickling, dry cough

Nux vomica.................................................stuffy nose, especially at night

Phosphoricum acidum...................................difficult breathing

Rhus toxicodendron......................................heaviness of chest, bronchial cough

Silicea........................................................coughs when lying down

Stramonium................................................deep snoring

Zincum metallicum.......................................hoarseness

Indications & Usage

Uses for temporary relief of symptoms related to snoring: •slow, labored breathing •stuffy nose, especially at night •heaviness of chest •dry cough

Warnings

Warnings

  • If symptoms persist or worsen, seek advice of a physician.
    • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Dosage & Administration

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth
  • Adults: 3 sprays 3 times per day.
  • Children Ages 2-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

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

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Otc - Purpose

Uses for temporary relief of symptoms:

  • slow, labored breathing
  • stuffy nose, especially at night
  • heaviness of chest
  • dry cough

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