Aches - Pains 2382l

Aches - Pains 2382l
SPL v3
SPL
SPL Set ID 7923c9ad-6078-f496-e053-2991aa0a15c4
Route
ORAL
Published
Effective Date 2018-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Silver Cation (6 [hp_X]) Arnica Montana Bryonia Alba Root Colchicum Autumnale Bulb Guaiac Hypericum Perforatum Kalmia Latifolia Leaf Phosphorus Phytolacca Americana Root Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Lactic Acid, L- Lobaria Pulmonaria Datura Stramonium Hamamelis Virginiana Root Bark/stem Bark Taraxacum Officinale
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-10-26 Until 2019-08-01

Description

Warnings: Keep our 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.

Purpose

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.


Medication Information

Purpose

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Description

Warnings: Keep our 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.

Package Label

Warnings Section

Warnings: Keep our 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.

Otc Purpose Section

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Otc 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 dispensing alcohol 20%.

Indications & Usage Section

Aches - Pains Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 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.

Otc Active Ingredient Section

Active Ingredients: Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 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 our 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.

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Otc Questions Section (OTC - 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 dispensing alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Aches - Pains Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 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.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Active Ingredients: Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 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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