Colic Relief
FDA Label NDC 57955-5158

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 Colic Relief (NDC 57955-5158). 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 ingredient, purposes, directions, warnings, otc - keep out of reach of children, uses, 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

Official HPUS: Aethusa cynapium, Alumina, Belladonna, Borax, Chamomilla, Colocynthis, Dioscorea villosa, Ipecacuanha, Magnesia phosphorica, Natrum phosphoricum, Nux vomica, Plumbum metallicum, Pulsatilla, Senna, Silicea, Valeriana officinalis.


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Inactive Ingredient

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.


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Purposes

Uses for temporary relief of:

  • abdominal discomfort, pressure, and distention
  • spitting up
  • gas and bloating
  • cramping
  • pain
  • irritability
  • desire to be held constantly
  • weak digestion
  • restless sleep
    • Enhanced digestive ability, especially for milk.

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Directions

Directions Initially depress pump until primed.  Hold close to mouth and spray directly into mouth.  Use 3 times daily.  Use additionally as needed.

Adult dose - 3 pump sprays

Children 2-12 years - 2 pump sprays



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Warnings

If symptoms persist or worsen, consult a physician.  If pregnant or nursing, take only on advice of healthcare professional. 

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

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Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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Uses

Uses for temporary relief of abdominal discomfort, pressure, and distention, spitting up, gas and bloating, cramping, pain, irritability, desire to be held constantly, weak digestion, restless sleep.

Enhances digestive ability, especially for milk.

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Package Label.Principal Display Panel


King Bio, Inc.

3 Westside Dr.

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

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