AVENA SATIVA by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AVENA SATIVA liquid

AVENA SATIVA by

Drug Labeling and Warnings

AVENA SATIVA by is a Homeopathic medication manufactured, distributed, or labeled by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

AVENA SATIVA HPUS 1X and higher

USES

USES: Temporary Relief - Difficulty Falling Asleep*

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

WARNINGS

This product is to be used for self-limiting conditions

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

Keep this and all medication out of reach of children

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVENA SATIVA 
avena sativa liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15631-2620
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	1 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15631-2620-0	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2024
2	NDC: 15631-2620-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/23/2024

Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)

Establishment
Name	Address	ID/FEI	Business Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-2620) , label(15631-2620)