CHILDBIRTH CARE- arnica, caulophyllum, cimicifuga, gelsemium, pulsatilla liquid
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.

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Childbirth 4642L-Dis

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

WARNINGS SECTION

Warning: Keep out of reach of children. Do not use, if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water, USP Gluten-free, non-GMO, organic cane alcohol 20%.

INDICATIONS & USAGE SECTION

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

PURPOSE SECTION

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

ACTIVE INGREDIENT SECTION

Equa parts of Arnica 15x, Caulophyllum 15x, Cimicifuga 15x, Gelsemium 15x, Pulsatilla 15x.

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL

Package Label

CHILDBIRTH CARE
arnica, caulophyllum, cimicifuga, gelsemium, pulsatilla liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4642
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	15 [hp_X] in 1 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	15 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	15 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4642-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	01/31/2019
2	NDC:55714-4642-2	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2017	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4642)

Revised: 10/2019

Document Id: 9407cb6d-7ebd-6cd6-e053-2a95a90aaa24

Set id: 603f3828-0d33-3273-e053-2991aa0a0ad3

Version: 2

Effective Time: 20191003

Newton Laboratories, Inc.