FDA Label for Cough Drops 2014

View Indications, Usage & Precautions

Cough Drops 2014 Product Label

The following document was submitted to the FDA by the labeler of this product Professional Complementary Health Formulas. 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.

Active Ingredients



Spongia tosta 2X
Belladonna 3X
Ipecacuanha 3X
Rumex crispus 3X
Senega officinalis 3X
Kali sulphuricum 4X
Mentha piperita 4X
Pulsatilla 4X
Arsenicum iodatum 6X
Drosera rotundifolia 6X
Hepar sulphuris calcareum 6X
Sanguinaria canadensis 6X
Bryonia 12X
Kali bichromicum 12X


Questions



Professional Formulas

PO Box 2034 Lake Oswego, OR 97035


Indications



Temporarily reduces the intensity of coughing.*


Otc - Purpose



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a healthcare professional before use.


Directions



Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.


Other Information



Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.


Inactive Ingredients



20% ethanol, purified water.


Label



Est 1985

Professional Formulas

Complementary Health

Cough Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)


* Please review the disclaimer below.