Childrens Colic Relief
FDA Label NDC 47242-0201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeostasis Laboratories, Inc. for the product Childrens Colic Relief (NDC 47242-0201). 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, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, questions? call toll free or email us at:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsPurpose
Antimonium crudum 6C, HPUSRelieves reflux after eating
Chamomilla 6C, HPUSRelieves stomach pains
Lycopodium Clavatum 6C, HPUSRelieves gas
Nux vomica 6C, HPUS 6C, HPUSRelieves upset stomach
Pulsatilla 6C, HPUSRelieves abdominal pains

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Children's digestive aid.

Uses

For the relief of gas pains and abdominal pains from eating, over-eating, or undigested food.

Safe for babies 6 weeks and older (if younger than 6 weeks consult your doctor first).

Warnings

  • Do not use if outer package seal is broken.
  • Stop use and consult a doctor if symptoms do not improve within 3 days, worsen or are accompanied by a fever over 101˚F.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Directions

Give child one tablet and allow to chew or dissolve in the mouth. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child.

Repeat every 4 hours as needed.

Other Information

  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source).

Questions? Call Toll Free Or Email Us At:

1-888-60-B-WELL (1-888-602-9355)

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