Upper Gi Restoration
FDA Label NDC 57955-0325

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 Upper Gi Restoration (NDC 57955-0325). 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, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, 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

Otc - Active Ingredient

HPUS active ingredients:

​Aceticum ac, Agaricus musc, Aloe, Antimon crud, Arg nit, Carbo veg, Carduus mar, Chelidonium maj, Chenopodium anth, Cinchona, Graphites, Ipecac, Lac deflor, Mentha pip, Nux vom, Secale, Tanacetum, Teucrium mar, Zingiber.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

Indications & Usage

Uses for temporary relief of: upper gastrointestinal distress: heartburn, gas, nausea, bloating, slow digestion, flatulence, vomiting, sensitive stomach.

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicer japonica (honeysuckle), polylysine, steviol glycosides

Warnings

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

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 2-12 years: 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. This product has not been clinically tested.

Otc - Purpose

Uses for ​temporary relief of symptoms of upper gastrointestinal distress:

  • heartburn
  • gas
  • nausea
  • bloating
  • slow digestion
  • flatulence
  • vomiting
  • sensitive stomach

* Please review the disclaimer below.