Food Intolerances
FDA Label NDC 57955-0728

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 Food Intolerances (NDC 57955-0728). 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.

Otc - Active Ingredient

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Allium sativum, Anacardium orientale, Apis Mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur

Equal volumes of each ingredient in 10X, 30X, and 1LM potencies.

Indications & Usage

Uses ​for temporary relief of symptoms from food chemical intolerances and sensitivities: headache, irritability, stomach cramps, indigestion, nausea, constipation, diarrhea, gas, heartburn, bloating.

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysukle), polylysine (natural ferment), steviol glycosides (stevia).

Warnings

Warnings

  • If symptoms persist or worsen, consult 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 tp to 6 times per day.

Other Safety Information

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

Otc - Purpose

Purpose:

Allium sativum.....heavy head

Anacardium orientale......nausea

Apis Mellifica......nausea, headache, irritability

Gambogia........gas, boating

Mercurius solubilis.....sensitive stomach

Natrum carbonicum.....headache

Nitricum acidum....nausea after eating

Nux vomica....constipation, diarrhea

Phosphorus....heartburn

Pulsatilla.....stomach cramps after eating

Sulphur......headache, irritability, sensitive stomach

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