Prime 4763l

Prime 4763l
SPL v2
SPL
SPL Set ID 99751ba5-77c2-2e89-e053-2a95a90a1269
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chaste Tree (15 [hp_X]) Garlic (6 [hp_X]) Ambergris Angelica Sinensis Root American Ginseng Arnica Montana Arsenic Cation (3+) Avena Sativa Flowering Top Baptisia Tinctoria Root Lachesis Muta Venom Barium Cation Bryonia Alba Root Lytta Vesicatoria Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Phosphoric Acid Anemone Pulsatilla Ruta Graveolens Flowering Top Saw Palmetto Selenium Zinc Ginkgo
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Indications and Usage

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Purpose

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Dosage and Administration

Directions: Adults, take 6 drops orally one to four times daily or as directed by a health professional.


Medication Information

Indications and Usage

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Purpose

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Dosage and Administration

Directions: Adults, take 6 drops orally one to four times daily or as directed by a health professional.

Description

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

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 associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Inactive Ingredient Section

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

Indications and Usage Section

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Otc Active Ingredient Section

Equal parts of Ginkgo biloba 6x, Ruta graveolens 6x, Agnus castus 15x, Allium sativum 15x, Ambra grisea 15x, Angelica sinensis radix 15x, Aralia quinquefolia 15x, Arnica montana 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Baryta carbonica 15x, Bryonia 15x, Cantharis 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Nux vomica 15x, Phosphoricum acidum 15x, Pulsatilla 15x, Ruta graveolens 15x, Sabal serrulata 15x, Selenium metallicum 15x, Zincum metallicum 15x.

Dosage and Administration Section

Directions: Adults, take 6 drops orally one to four times daily or as directed by a health professional.

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 associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

Formulated for symptoms associated with age-related conditions such as forgetfullness, weakness, joint pain, and decreased libido.

Otc Active Ingredient Section (OTC ACTIVE INGREDIENT SECTION)

Equal parts of Ginkgo biloba 6x, Ruta graveolens 6x, Agnus castus 15x, Allium sativum 15x, Ambra grisea 15x, Angelica sinensis radix 15x, Aralia quinquefolia 15x, Arnica montana 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Baryta carbonica 15x, Bryonia 15x, Cantharis 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Nux vomica 15x, Phosphoricum acidum 15x, Pulsatilla 15x, Ruta graveolens 15x, Sabal serrulata 15x, Selenium metallicum 15x, Zincum metallicum 15x.

Dosage and Administration Section (DOSAGE AND ADMINISTRATION SECTION)

Directions: Adults, take 6 drops orally one to four times daily or as directed by a health professional.

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)