Childbirth 4642L-Dis

Drug Labeling and Warnings

Drug Details [pdf]

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 55714-4642
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT15 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH15 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-4642-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/17/201701/31/2019
2NDC: 55714-4642-259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/17/201701/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/17/201701/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4642)

Revised: 10/2019
Document Id: 9407cb6d-7ebd-6cd6-e053-2a95a90aaa24
Set id: 603f3828-0d33-3273-e053-2991aa0a0ad3
Version: 2
Effective Time: 20191003