Childrens Earache Relief
FDA Label NDC 47242-0221

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 Earache Relief (NDC 47242-0221). 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
Aconitum napallus 6C, HPUSRelieves sudden onset of ear pain
Arsenicum album 6C, HPUSRelieves runny nose & restlessness
Chamomilla 6C, HPUSRelieves irritability and pain
Mercurius solubilis 6C, HPUSEliminates discharge from ears
Pulsatilla 6C, HPUSRelieves ear pain and weepy mood
Silicea 6C, HPUSRelieves ear pain

"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: Relief of ear pain in children.

Uses

For the relief of acute inflammation of the ear, pain, high fever and discharge from the ears.

Safe for children 6 months and older (if younger than 6 months 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 persistent 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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