FDA.reportPublic FDA data

Childbirth Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-10-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:07:57

Label at a glance#

ProductChildbirth Care
Active ingredientCAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, GELSEMIUM SEMPERVIRENS ROOT, PULSATILLA VULGARIS, ARNICA MONTANA
Label structure10 sections

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

OTC - 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

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

PURPOSE SECTION

INDICATIONS & USAGE SECTION

Formulated for associated emotional and physical symptoms such as pelvic pain, fear and tearful, labor pains.

ACTIVE INGREDIENT SECTION

OTC - 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

Formulated for emotional and physical symptoms such as pelvic pain, fear, and tearful, labor pains.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-481755714-4817-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SUCROSEC151H8M554IACT
ARNICA MONTANAO80TY208ZWACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b58119bd-8706-8442-e053-2a95a90a5a719494d21f-6c97-f464-e053-2995a90a93e62020-12-02WarningsExact identifier
spl set id: 9494d21f-6c97-f464-e053-2995a90a93e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.