Childbirth 4643P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

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

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Childbirth 4643P-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: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

PURPOSE SECTION

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

ACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4643
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4643-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	01/31/2019

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

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4643)

Revised: 10/2019

Document Id: 947d0444-bf98-5f4a-e053-2995a90a23ff

34391-3

Set id: 603c6f3e-5d02-0746-e053-2a91aa0a579b

Version: 2

Effective Time: 20191009