Childrens Cough And Cold Relief
FDA Label NDC 47242-0211

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 Cough And Cold Relief (NDC 47242-0211). 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
Arsenicum album 6C, HPUSRelieves runny nose & restlessness
Drosera rotundifolia 6C, HPUSRelieves night timecough
Ferrum phosphoricum 6C, HPUSRelieves loss of energy
Pulsatilla 6C, HPUSRelieves excessive mucus in nasal passage
Sambucus nigra 6C, HPUSRelieves bronchial cough
Silicea 6C, HPUSRelieves runny nose
Spongia tosta 6C, HPUSRelieves barking cough

"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 antitussive.

Uses

For relief of deep coughs, cold, runny nose and excessive mucus in nasal passage & lungs.

Safe for children 2 years and older (if younger than 2 years consult your doctor first).

Warnings

  • Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema.
  • 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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