Breast 2394l

Breast 2394l
SPL v3
SPL
SPL Set ID 79edde91-f909-f7b3-e053-2991aa0a9d1c
Route
ORAL
Published
Effective Date 2018-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bufo Bufo Cutaneous Gland (15 [hp_X]) Apis Mellifera (6 [hp_X]) Asterias Rubens Atropa Belladonna Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Matricaria Recutita Chimaphila Umbellata Cinchona Officinalis Bark Conium Maculatum Flowering Top Croton Tiglium Seed Echinacea, Unspecified Graphite Chamaelirium Luteum Root Lachesis Muta Venom Mercury Oenanthe Aquatica Fruit Phosphorus Phytolacca Americana Root Pulsatilla Vulgaris Sanguinaria Canadensis Root Silicon Dioxide Hamamelis Virginiana Root Bark/stem Bark Ruta Graveolens Flowering Top Taraxacum Officinale
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-11-05 Until 2019-08-01

Description

Keep out of reach of children.

Purpose

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.


Medication Information

Purpose

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Description

Keep out of reach of children.

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 symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Dosage & Administration Section

Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 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)

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 associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 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


Raw Label Data

All Sections (JSON)