Avena Valeriana by Uriel Pharmacy Inc AVENA VALERIANA pellet

Avena Valeriana by

Drug Labeling and Warnings

Avena Valeriana 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: Avena (Oats) 3X, Valeriana (Valerian) 3X, Conchae (Oyster shells) 7X, Phosphorus (Yellow phosphorus) 30X, Sulfur 30X

INACTIVE INGREDIENT

Inactive Ingredients: Organic sucrose, Lactose

PURPOSE

Use: Temporary relief for sleeplessness and nerves.

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. Contains traces of lactose. 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

AVENA VALERIANA 
avena valeriana pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1279
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]
OSTREA EDULIS SHELL (UNII: 49OY13BE7Z) (OSTREA EDULIS SHELL - UNII:49OY13BE7Z)	OSTREA EDULIS SHELL	7 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_X]

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1279-2	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(48951-1279)