FRAGARIA VESCA- fragaria vesca fruit pellet

Fragaria vesca by

Drug Labeling and Warnings

Fragaria vesca by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Fragaria vesca 200CK HPUS

Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

PURPOSE

INDICATIONS & USAGE

Uses: See symptoms on front panel.

Relieves hives *

WARNINGS

STOP USE

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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

QUESTIONS

BoironUSA.com Info@boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRAGARIA VESCA 
fragaria vesca fruit pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-2149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) (FRAGARIA VESCA FRUIT - UNII:CG6IX3GCMU)	FRAGARIA VESCA FRUIT	200 [kp_C]  in 200 [kp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-2149-41	200 [kp_C] in 1 TUBE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2024

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-2149)