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 Ingredients | Purpose |
Arsenicum album 6C, HPUS | Relieves runny nose & restlessness |
Drosera rotundifolia 6C, HPUS | Relieves night timecough |
Ferrum phosphoricum 6C, HPUS | Relieves loss of energy |
Pulsatilla 6C, HPUS | Relieves excessive mucus in nasal passage |
Sambucus nigra 6C, HPUS | Relieves bronchial cough |
Silicea 6C, HPUS | Relieves runny nose |
Spongia tosta 6C, HPUS | Relieves 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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