AVENA SATIVA COMP. liquid

Avena sativa comp. by

Drug Labeling and Warnings

Avena sativa comp. 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

Take 3-4 times daily. Ages 12 and older: 10 drops.
Ages 2-11: 5 drops. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: 100gm contains: 25gm Avena sativa (Oats) 1X, 1.2gm Humulus lupulus (Common Hop) 1X, 7.5gm Passiflora ex herba (Passionflower) 1X, 30gm Valeriana e rad Dec. (Valerian) 1X, Coffea tosta (Coffea seed) 60X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, 45% Organic cane alcohol

Prepared using rhythmical processes.

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. 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
Made with care by Uriel, East Troy, WI 53120
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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVENA SATIVA COMP. 
avena sativa comp. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1379
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	1 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]  in 1 mL
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E)	COFFEA ARABICA SEED, ROASTED	60 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X]  in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1379-3	60 mL in 1 BOTTLE, DROPPER; 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(48951-1379)