CHILDBIRTH SUPPORT - arnica montana, caulophyllum thalictroides root, black cohosh, gelsemium sempervirens root and pulsatilla vulgaris pellet
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT NAME & INDICATIONS SECTION

CHILDBRITH SUPPORT Formulated for emotional and physical support during final stages of pregnancy, labor and delivery.

DIRECTION SECTION

Directions: Ages 12 and up, take 3 to 6 pellets orally three times daily or as directed by a healthcare professional. Warning: To be used at or after 36 weeks of pregnancy.

ACTIVE INGREDIENT SECTION

Arnica 15x, Caulophyllum 15x, Cimicifuga 15x, Gelsemium 15x, Pulsatilla 15x.

PURPOSE SECTION

Formulated for emotional and physical support during final stages of pregnancy, labor and delivery.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

CHILDBIRTH SUPPORT
arnica, caulophyllum, cimicifuga, gelsemium, pulsatilla pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4591
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Arnica Montana (Arnica Montana)	Arnica Montana	15 [hp_X] in 1 g
Caulophyllum Thalictroides Root (Caulophyllum Thalictroides Root)	Caulophyllum Thalictroides Root	15 [hp_X] in 1 g
Black Cohosh (Black Cohosh)	Black Cohosh	15 [hp_X] in 1 g
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 g
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose

Packaging
#	Item Code	Package Description
1	NDC:55714-4591-1	28.35 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE, API MANUFACTURE

Revised: 06/2011

Document Id: cd0b7dd8-5b82-e70a-6ceb-63f4e5dddbbe

Set id: e90f5c0c-d59f-9c1c-ba69-371a016e78a3

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.