FDA.reportPublic FDA data

Childbirth Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:44

Label at a glance#

ProductChildbirth Care
Active ingredientARNICA MONTANA, BLACK COHOSH, GELSEMIUM SEMPERVIRENS ROOT, ANEMONE PULSATILLA, CAULOPHYLLUM THALICTROIDES ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 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.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Arnica montana 15x, Caulophyllum thalictroides 15x, Cimicifuga racemosa 15x, Gelsemium sempervirens 15x, Pulsatilla 15x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

WARNINGS SECTION

WARNINGS: 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4837-1Childbirth Care28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4837CHILDBIRTH CARE (ARNICA MONTANA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, PULSATILLA.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201203_9a9fd3fb-7142-4620-e053-2a95a90a5e30.zip

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
55714-483755714-4837-1

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
SUCROSEC151H8M554IACT
ARNICA MONTANAO80TY208ZWACTIB
BLACK COHOSHK73E24S6X9ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB

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
Childbirth CareARNICA MONTANA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, PULSATILLA.Newton Laboratories, Inc.9a9fd3fb-7142-4620-e053-2a95a90a5e302020-12-02WarningsExact identifier
ndc (package): 55714-4837-1
ndc (product): 55714-4837
ndc11 (package): 55714483701
spl id: b580f381-9542-19fb-e053-2995a90af977
spl set id: 9a9fd3fb-7142-4620-e053-2a95a90a5e30

Reported adverse events (FAERS/openFDA)#

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