Food Intolerances
FDA Label NDC 57955-8300

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 57955-8300). 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, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, 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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Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

HPUS active ingredients: Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur.

Indications & Usage

Uses for temporary relief of symptoms associated with food intolerances and sensitivities:

  • headache
  • irritability
  • stomach cramps and indigestion
  • nausea
  • gas, heartburn and bloating
  • constipation
  • diarrhea
  • sensitivities to meat, fat, salt, dairy, starches and vegetables.

Warnings

Warnings

  • Stop use and ask a doctor if symptoms persist or worsen.
  • 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 6-12: 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 is intended to complement, not replace, standard medical care.

Inactive Ingredient

Inactive Ingredients: Citric acid, potassium sorbate, purified water.

Otc - Purpose

Drug Facts

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HPUS active ingredients                                                                    Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Aethusa cynapium..........................................................................headache, irritability

Calcarea carbonica.........................................................................aversion to meat, fat and milk

Cucurbita pepo, semen...................................................................nausea after eating

Gambogia.....................................................................................sneezing, diarrhea

Histaminum hydrochloricum............................................................stomach cramps

Hydrastis canadensis......................................................................sensitivities to bread or vegetables

Lycopodium clavatum.....................................................................indigestion

Natrum carbonicum........................................................................sensitivities to milk, diarrhea

Nitricum acidum.............................................................................constipation

Nux vomica...................................................................................nausea after eating, stomach cramps

Ovi gallinae pellicula.......................................................................sensitivities to eggs

Phosphorus....................................................................................sensitivities to salt, nausea

Pulsatilla........................................................................................gas, heartburn, bloating

Sulphur..........................................................................................loss of appetite, sensitivities to dairy

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