Throat 2578l

Throat 2578l
SPL v1
SPL
SPL Set ID 0fb69003-c66c-97ad-e063-6394a90a4c9b
Route
ORAL
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Verbascum Thapsus (15 [hp_X]) Arisaema Dracontium Root (16 [hp_X]) Atropa Belladonna (6 [hp_X]) Mentha Piperita Ulmus Rubra Bark Phytolacca Americana Root Anemone Pulsatilla Echinacea, Unspecified Aconitum Napellus Apis Mellifera Bryonia Alba Root Cajuput Oil Mercury Naja Naja Venom Dichromate Ion Lachesis Muta Venom Carbonate Ion Sodium Sulfate Anhydrous Nitric Acid Strychnos Nux-vomica Whole Phosphorus Spongia Officinalis Skeleton, Roasted Lobaria Pulmonaria Thuja Occidentalis Leafy Twig Ferrosoferric Phosphate Glycyrrhiza Glabra Tin
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-01-24

Description

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

Indications and Usage

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

Purpose

Formulated for associated symptoms such as dryness, irrtiation, inflammation, pain and hoarseness.


Medication Information

Indications and Usage

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

Purpose

Formulated for associated symptoms such as dryness, irrtiation, inflammation, pain and hoarseness.

Description

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

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 dryness, irrtiation, inflammation, pain and hoarseness.

Inactive Ingredient Section

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

Indications and Usage Section

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

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

Equal parts of Echinacea 6x, Aconitum nap. 15x, Apis mel. 15x, Arum drac. 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phos. 15x, Glycyrrhiza 16x, Kali bic. 15x, Lachesis 15x, Menta pip. 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulv. 16x, Verbascum 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

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.


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 dryness, irrtiation, inflammation, pain and hoarseness.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.

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)

Equal parts of Echinacea 6x, Aconitum nap. 15x, Apis mel. 15x, Arum drac. 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phos. 15x, Glycyrrhiza 16x, Kali bic. 15x, Lachesis 15x, Menta pip. 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulv. 16x, Verbascum 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)

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.


Advanced Ingredient Data


Raw Label Data

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