FDA Label for Cocculus Indicus
View Indications, Usage & Precautions
Cocculus Indicus Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. 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
Cocculus indicus 5C
(**contains 0.443 mg of the active ingredient per pellet)
Indications & Usage
Motion sickness with a need to lie down*
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Other
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Inactive Ingredient
lactose, sucrose
Dosage & Administration
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Package Label.Principal Display Panel
* Please review the disclaimer below.