Arnica Betula B by Uriel Pharmacy Inc. ARNICA BETULA B pellet

Arnica Betula B by

Drug Labeling and Warnings

Arnica Betula B by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: Betula (Silver birch leaves) 3X, Betula cort. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quad. (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (Bovine Myelencephalon 17X, Nervus stat. (Bovine eighth cranial nerve) 17X, Arnica 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 30X, Plumbum mellitum (Lead with honey) 30X

INACTIVE INGREDIENT

Inactive Ingredient: Organic sucrose

PURPOSE

Use: Temporary relief of headache.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

QUESTIONS

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA BETULA B 
arnica betula b pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) (BETULA PUBESCENS LEAF - UNII:84SOH0O3OO)	BETULA PUBESCENS LEAF	3 [hp_X]
BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9)	BETULA PUBESCENS BARK	4 [hp_X]
BOS TAURUS CEREBELLUM (UNII: Q09851U44F) (BOS TAURUS CEREBELLUM - UNII:Q09851U44F)	BOS TAURUS CEREBELLUM	17 [hp_X]
BOS TAURUS BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z)	BOS TAURUS BRAIN	17 [hp_X]
BOS TAURUS PINEAL GLAND (UNII: Z7RM5NBH36) (BOS TAURUS PINEAL GLAND - UNII:Z7RM5NBH36)	BOS TAURUS PINEAL GLAND	17 [hp_X]
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV)	SUS SCROFA EAR	17 [hp_X]
BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK)	BOS TAURUS NERVE	17 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]
BIFENTHRIN (UNII: 6B66JED0KN) (BIFENTHRIN - UNII:6B66JED0KN)	BIFENTHRIN	30 [hp_X]
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	30 [hp_X]
HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH)	HONEY	30 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1117-2	1350 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2009

Labeler - Uriel Pharmacy Inc. (043471163)

Establishment
Name	Address	ID/FEI	Business Operations
Uriel Pharmacy Inc.		043471163	manufacture(48951-1117)