Female 4769l

Female 4769l
SPL v2
SPL
SPL Set ID 9a01acb9-1b2b-3a33-e053-2995a90adc92
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Goldenseal (15 [hp_X]) Ustilago Maydis Arsenic Cation (3+) Calcium Cation Carbo Animalis Conium Maculatum Flowering Top Graphite Iodine Wood Creosote Lachesis Muta Venom Phosphorus Juniperus Sabina Leafy Twig Claviceps Purpurea Sclerotium Sepia Officinalis Juice Silicon Dioxide Capsella Bursa-pastoris Thuja Occidentalis Leafy Twig Thyroid, Unspecified Trillium Erectum Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Purpose

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.


Medication Information

Purpose

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Description

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

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 symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional

Otc Active Ingredient Section

Equal parts of Hydrastis canadensis 6x, Thuja occidentalis 6x, Arsenicum album 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium maculatum 15x, Graphites 15x, Hydrastis canadensis 15x, Iodium 15x, Kreosotum 15x, Lachesis mutus 15x, Phosphorus 15x, Sabina 15x, Secale cornutum 15x, Sepia 15x, Silicea 15x, Thlaspi bursa-pastoris 15x, Thuja occidentalis 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 1

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)

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 (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 symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Hydrastis canadensis 6x, Thuja occidentalis 6x, Arsenicum album 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium maculatum 15x, Graphites 15x, Hydrastis canadensis 15x, Iodium 15x, Kreosotum 15x, Lachesis mutus 15x, Phosphorus 15x, Sabina 15x, Secale cornutum 15x, Sepia 15x, Silicea 15x, Thlaspi bursa-pastoris 15x, Thuja occidentalis 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 1

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


Raw Label Data

All Sections (JSON)