Upper Gi Restoration
FDA Label NDC 57955-0321

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 57955-0321). 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

Drug Facts

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HPUS active ingredients: Aceticum acidum, Agaricus muscarius, Aloe socotrina, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum, Zingiber officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Indications & Usage

Uses temporarily relieves symptoms of upper gastrointestinal distress: heartburn, gas, nausea, bloating, slow digestion, flatulence, vomiting, sensitive stomach.

Inactive Ingredient

Inactive ingredients: Bio-Energetically Enhanced™ pure water base, citric acid, potassium sorbate.

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.

Otc - Purpose

Uses temporarily relieves symptoms of upper gastrointestinal distress:

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

* Please review the disclaimer below.