Sprayology Digestivease
FDA Label NDC 61096-0005

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 Digestivease (NDC 61096-0005). 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: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

Warnings

Warnings: If symptoms persist or worsen, 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 each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
  • Ages 2 to 12: 1 spray into the mouth each 30 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter. Under age 2: consult a health care professional.

Otc - Purpose

Temporarily relieves symptoms of gastric distress, including:

  • nausea and food poisoning
  • flatulence
  • indigestion and heartburn
  • stomach cramps

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 and purified water.

Indications & Usage

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning

° flatulence

° indigestion and heartburn

° stomach cramps

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

Package Label.Principal Display Panel

Image Description (Digestivease)

Image Description (Digestivease)

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