Irritable Bowelcare
FDA Label NDC 57955-4020

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 Irritable Bowelcare (NDC 57955-4020). 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 active ingredients, inactive ingredients, purpose, indications and usage, warnings, otc - keep out of reach of children, dosage and administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

HPUS active ingredientsEqual volumes of each ingredient in 10X, 30X and LM1 potencies.Aloe socotrina, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Croton tiglium, Gelsemium sempervirens, Gratiola officinalis, Nux vomica,Phosphoricum acidum, Podophyllum peltatum and Veratrum album.Reference image bowelcare.jpg

Inactive Ingredients

Purified water, Potassium sorbate and citric acid.

Reference image bowelcare.jpg

Purpose

HPUS active ingredients                                     Purpose

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

Aloe socotrina...............................................................diarrhea, mucus in stools
Carbo vegetabilis...........................................................stomach cramps, gas, nausea
Chamomilla...................................................................abdominal pain, bloating, gas
Cinchona officinalis........................................................loose stools, abdominal pain
Collinsonia canadensis...................................................rectal pain, constipation
Colocynthis...................................................................abdominal cramps, pain
Croton tiglium................................................................sudden evacuation of stools
Gelsemium sempervirens...............................................urgent need to pass stools
Gratiola officinalis..........................................................stomach cramps, diarrhea
Nux Vomica..................................................................alternating constipation and diarrhea
Phosphoricum acidum...................................................diarrhea, gas, bloating
Podophyllum peltatum....................................................alternating constipation and diarrhea
Veratrum album.............................................................irregularity, difficult elimination

Reference image bowelcare.jpg

Indications And Usage


Uses for temporary relief of irritable bowel symptoms:

  • diarrhea
  • abdominal pain
  • alternating constipation and diarrhea
  • bloating
  • gas
  • nausea
  • abdominal cramps
  • mucus in stools
  • urgent need to pass stools
  • irregularity
  • difficult elimination
    • as per various homeopathic Materia Medicas.

Warnings

  • If symptoms persist or worsen, seek advice of a physician.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • Keep out of reach of children.
    • Other information
    Tamper resistant for your protection. Use only if safety seal is intact.

    Reference image bowelcare.jpg

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage And Administration

Directions

  • Initially, depress pump until primed.
  • Hold bottle close to mouth and spray one dose directly into mouth
  • Adults and children 12 years and older:3 pumps sprays.
  • Use from 3 to 6 times per day as needed.
    • Reference image bowelcare.jpg

Package Label.Principal Display Panel

Image Of Carton (Bowelcare)

Image Of Carton (Bowelcare)


King Bio, Inc.

3 Westside Drive

Asheville, NC 28806

For questions or more information about homeopathy call 800-543-3245 or www.safe-care.com

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