Probiotic Restoration
FDA Label NDC 57955-3320

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 Probiotic Restoration (NDC 57955-3320). 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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HPUS active ingredients

Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colcynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia, Silicea.

Indications & Usage

Uses temporarily relieves symptoms of intestinal discomfort such as:

  • diarrhea
  • abdominal tenderness and distention
  • bloating
  • cramps
  • rumbling in bowels
  • flatulence
  • colic
  • constipation
  • hemorrhoids
  • nausea
  • irritated bowel
  • mucous inflammation

Warnings

​Warnings​

  • If symptoms persist or worsen, seek advice of 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 say.
  • Children ages 2-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

Other information

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

Inactive Ingredient

Inactive ingredients: ​Bio-Energetically enhanced™ pure water, citric acid and potassium sorbate.

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......................................................pain, colic

Allium sativum...........................................................voracious appetite, constipation

Baptisia tinctoria........................................................bad breath, sore abdomen in region of liver

Capsicum annuum......................................................pain in back after stool, flatulence

Carbo vegetabilis........................................................nausea, burning, heaviness and fullness in abdomen

Chamomilla................................................................flatulent colic, hot, watery or slimy stools

Cinchona officinalis.....................................................gas, milk intolerance

Collinsonia canadensis.................................................hemorrhoids, constipation

Colocynthis................................................................intestine feels as if bruised

Condurango...............................................................stomach ulcerations

Gambogia..................................................................abdominal pain and distention, stomach mucus

Gratiola officinalis.......................................................intesinal mucus, cramps and colic

Lac vaccinum.............................................................bloating, sour taste in mouth, constipation

Lacticum acidum........................................................nausea, burning gas, profuse mucus

Natrum carbonicum....................................................weak digestion

Nux vomica...............................................................flatulent distention in the abdomen, colic

Podophyllum peltatum................................................diarrhea, constipation, hemorrhiods

Sepia.......................................................................flatulence with headache, consipation

Silicea......................................................................rumbling in bowels

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