FDA Label for Cough And Cold Relief
View Indications, Usage & Precautions
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 |
Allium cepa 30C, HPUS | Relieves runny nose |
Arsenicum album 30C, HPUS | Relieves runny nose |
Ferrum phosphoricum 30C, HPUS | Relieves loss of energy |
Lac caninum 30C, HPUS | Relieves throat irritation |
Natrum muriaticum 30C, HPUS | Relieves sneezing |
Nux vomica 30C, HPUS | Relieves stuffy nose |
"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: Antitussive.
Uses
Relieves severe cough, runny nose and sneezing due to throat or bronchial irritation associated with the common cold.
Warnings
- Do not use if outer package seal is broken.
- A persistent cough may be a sign of a serious condition. If a cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, stop use and consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
- Consult a doctor before use in children younger than 8 years of age.
Otc - Pregnancy Or Breast Feeding
- If pregnant or breast-feeding, consult a health professional before use.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Directions
(adults and children 8 years of age and older)
Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat with one tablet every 4 hours as needed until cold is gone.
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), stevia leaf extract.
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