FDA Label for Childrens Colic Relief

View Indications, Usage & Precautions

Childrens Colic Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeostasis Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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).


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