Otc - Active Ingredient
THEA SINENSIS 200CK HPUS
Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).
Thea Sinensis Pellet
FDA Label NDC 0220-4975
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Thea Sinensis (NDC 0220-4975). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Relieves sleeplessness with agitation *
Uses: See symptoms on front panel.
Warnings
Warnings
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.
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.
Inactive Ingredient
lactose, sucrose
Otc - Questions
BoironUSA.com [email protected]
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
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.
Package Label.Principal Display Panel
Label (Thea Sinensis 200ck Label)
* Please review the disclaimer below.
