Breast 4828l

Breast 4828l
SPL v3
SPL
SPL Set ID 98d01128-9887-12ce-e053-2a95a90a7329
Route
ORAL
Published
Effective Date 2019-09-02
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 Chamomilla 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 Anemone Pulsatilla 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 Active Since 2018-09-02

Description

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


Medication Information

Description

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

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

Inactive Ingredient Section

Inactive Ingredients: 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

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 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

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

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 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

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