FDA Label for Childrens Cough And Cold Relief

View Indications, Usage & Precautions

Childrens Cough And Cold 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
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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