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Bryophyllum Avena

Bryophyllum Avena

Approved
Approval ID

f3d21630-0a99-11df-8a39-0800200c9a66

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

Uriel Pharmacy Inc

DUNS: 043471163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bryophyllum Avena

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-2137
Product Classification
G
Generic Name
Bryophyllum Avena
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (9)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OATActive
Quantity: 3 [hp_X] in 1 mL
Code: Z6J799EAJK
Classification: ACTIB
VALERIANActive
Quantity: 3 [hp_X] in 1 mL
Code: JWF5YAW3QW
Classification: ACTIB
PHOSPHORUSActive
Quantity: 30 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
SULFURActive
Quantity: 30 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
KALANCHOE DAIGREMONTIANA LEAFActive
Quantity: 1 [hp_X] in 1 mL
Code: L6X13JKL8O
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 7 [hp_X] in 1 mL
Code: 2E32821G6I
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

Bryophyllum Avena Liquid

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/27/2010

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/27/2010

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/27/2010

Active Ingredients: Bryophyllum (Life plant) 1X, Avena (Oats) 3X, Valeriana (Valerian) 3X, Conchae (Oyster shells) 7X, Phosphorus (Yellow phosphorus) 30X, Sulfur 30X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/27/2010

Inactive Ingredients: Distilled water, Glycerin, Lactose

Prepared using rhythmical processes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/27/2010

KEEP OUT OF REACH OF CHILDREN.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/27/2010

Uses: Temporary relief of sleeplessness or nervous tension.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/27/2010

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

REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 30 DAYS OF OPENING.

SHAKE WELL BEFORE USE.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/27/2010

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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Bryophyllum Avena - FDA Drug Approval Details