Sprayology Snore Soother
FDA Label NDC 61096-0024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eight And Company for the product Sprayology Snore Soother (NDC 61096-0024). 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, warnings, otc - keep out of reach of children, dosage & administration, otc - purpose, other safety information, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: Antimonium tartaricum 200C, Carbo vegetabilis 12X, Mercurius corrosivus 200C, Mucosa nasalis suis 6X, Quebracho 3X, Sticta pulmonaria 200C, Teucrium marum 3X.

Warnings

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions:

  • Adults and children over 12: 2 sprays into the mouth 3 times per day, with the last dose taken at bedtime. Additional doses can be taken if sleep is interrupted.
  • Children under 12: consult a health care professional.
  • Not intended for the treatment of sleep apnea.

Otc - Purpose

Temporarily relieves the common symptoms of snoring including:

  • volume
  • frequency
  • tickling in throat
  • sudden waking from sleep

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v, purified water.

Indications & Usage

Temporarily relieves the common symptoms of snoring including:

° volume

° frequency

° tickling in throat

° sudden waking from sleep

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

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