Childbirth 4837p

SPL v2

SPL

SPL Set ID 9a9fd3fb-7142-4620-e053-2a95a90a5e30

Route

ORAL

Published

Effective Date 2019-09-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arnica Montana (15 [hp_X]) Black Cohosh Gelsemium Sempervirens Root Anemone Pulsatilla Caulophyllum Thalictroides Root

Inactive Ingredients

Sucrose

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

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

Purpose

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

Medication Information

Purpose

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

Description

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

Package Label

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.

Questions Section

newtonlabs.net - Questions? 800.448.7256

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

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.

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 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.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (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 (OTC - ACTIVE INGREDIENT SECTION)

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

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

[{"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "BLACK COHOSH", "unii": "K73E24S6X9", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "ANEMONE PULSATILLA", "unii": "I76KB35JEV", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "CAULOPHYLLUM THALICTROIDES ROOT", "unii": "JTJ6HH6YEH", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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.", "QUESTIONS SECTION": "newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013", "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.", "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 - 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:56.566872 · Updated: 2026-03-14T23:14:59.768699