Blues 2390l

Blues 2390l
SPL v5
SPL
SPL Set ID 79890e75-dfac-0262-e053-2a91aa0a5ce5
Route
ORAL
Published
Effective Date 2018-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (6 [hp_X]) Ginkgo (15 [hp_X]) Mahonia Aquifolium Root Bark Angelica Sinensis Root American Ginseng Silver Cation Arsenic Cation (3+) Capsicum Cinchona Officinalis Bark Digitalis Gelsemium Sempervirens Root Hypericum Perforatum Strychnos Ignatii Seed Iodine Bromide Ion Carbonate Ion Magnesium Cation Chloride Ion Phosphorus Salix Nigra Bark Sanguinaria Canadensis Root Sepia Officinalis Juice Datura Stramonium
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-10-31 Until 2019-07-01

Description

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

Purpose

Formulated for associated symptoms such as grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.


Medication Information

Purpose

Formulated for associated symptoms such as grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

Description

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

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is missing or broken. If symptoms persist for more than a few days, consult a doctor. If pregnant or breat-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 grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

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 grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms worsen or persist, especially if suicidal thouhts are present, consult a licensed health professional.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Ginkgo 6x, Angelica sin. 15x, Aralia quin. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Berber. aqui. 15x, Capsicum 15x, Cinchona 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Ignatia 15x, Iodium 15x, Kali brom. 15x, Kali carb. 15x, Mag. phos. 15x, Nat. carb. 15x, Nat. mur. 15x, Phos. 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Stramonium 15x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or brest-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 missing or broken. If symptoms persist for more than a few days, consult a doctor. If pregnant or breat-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 grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

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 grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms worsen or persist, especially if suicidal thouhts are present, consult a licensed health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Ginkgo 6x, Angelica sin. 15x, Aralia quin. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Berber. aqui. 15x, Capsicum 15x, Cinchona 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Ignatia 15x, Iodium 15x, Kali brom. 15x, Kali carb. 15x, Mag. phos. 15x, Nat. carb. 15x, Nat. mur. 15x, Phos. 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Stramonium 15x.

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

If pregnant or brest-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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