Betula Spiraea

Betula Spiraea
SPL v5
SPL
SPL Set ID 32604217-7955-492e-9df6-9e4882566ac4
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Betula Pubescens Bark (3 [hp_X]) Betula Pubescens Leaf (4 [hp_X]) Filipendula Ulmaria Root (7 [hp_X]) Mandragora Officinarum Root (10 [hp_X]) Lead (17 [hp_X]) Formica Rufa Arnica Montana Equisetum Arvense Top
Inactive Ingredients
Water Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2009-09-01

Description

Directions: FOR ORAL USE.


Medication Information

Warnings and Precautions

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.

Indications and Usage

Directions: FOR ORAL USE.

Dosage and Administration

Take the contents of one ampule

under the tongue and hold for

30 seconds, then swallow.

Description

Directions: FOR ORAL USE.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive Ingredients: Water, Salt

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com

Section 55105-1

Use: Temporary relief of sore muscles.

Section 55106-9

Active Ingredients: Betula e cort. decoct. (Silver birch, bark dried) 3X, Betula e fol. (Silver birch leaves) 3X, Spiraea (Meadowsweet) 3X, Mandragora (Mandrake) 4X, Galena (Lead glance) 7X, Formica (Red wood ant) 10X, Arnica 17X, Equisetum (Common horsetail) 17X


Structured Label Content

Indications and Usage (34067-9)

Directions: FOR ORAL USE.

Dosage and Administration (34068-7)

Take the contents of one ampule

under the tongue and hold for

30 seconds, then swallow.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Salt

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com

Section 55105-1 (55105-1)

Use: Temporary relief of sore muscles.

Section 55106-9 (55106-9)

Active Ingredients: Betula e cort. decoct. (Silver birch, bark dried) 3X, Betula e fol. (Silver birch leaves) 3X, Spiraea (Meadowsweet) 3X, Mandragora (Mandrake) 4X, Galena (Lead glance) 7X, Formica (Red wood ant) 10X, Arnica 17X, Equisetum (Common horsetail) 17X


Advanced Ingredient Data


Raw Label Data

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