Sinu-s 4778l

Sinu-s 4778l
SPL v2
SPL
SPL Set ID 9a667ff9-9438-2cef-e053-2995a90ac0a2
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (6 [hp_X]) Schoenocaulon Officinale Seed (15 [hp_X]) Arsenic Cation (3+) (16 [hp_X]) Bryonia Alba Root Helianthemum Canadense Calcium Sulfide Histamine Iodine Dichromate Ion Iodide Ion Mercuric Iodide Mercury Strychnos Nux-vomica Seed Phosphorus Anemone Pulsatilla Verbascum Thapsus Sinusitisinum Lobaria Pulmonaria Goldenseal
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

Purpose

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.


Medication Information

Purpose

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

Description

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

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 such as stuffy nose, cough, sinus pressure and low-grade fever.

Inactive Ingredient Section

I nactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Iodium 15x, Kali bichromicum 15x, Kali iodatum 15x, Mercurius iodatus ruber 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta pulmonaria 15x, Verbascum thapsus 15x, Sinusitisinum 16x.

Otc Keep Out of Reach of Children

Keep out of reach of children.

Otc Pregnancy Or Breast Feeding Section

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 symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

I nactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Iodium 15x, Kali bichromicum 15x, Kali iodatum 15x, Mercurius iodatus ruber 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta pulmonaria 15x, Verbascum thapsus 15x, Sinusitisinum 16x.

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

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

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


Advanced Ingredient Data


Raw Label Data

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