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Sinusitis

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Sinusitis


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRODUCT NAME & INDICATIONS SECTION

Sinusitis  Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Iodium 15x, Kali bic. 15x, Kali iod.15x, Merc. iod. rub. 15x, Merc. viv. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta 15x, Verbascum 15x , Echinacea 3x, Hydrastis 3x.

PURPOSE SECTION

Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Sinusitis

Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4418
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARSENIC TRIIODIDE ARSENIC TRIIODIDE 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
Helianthemum Canadense Helianthemum Canadense 15 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 15 [hp_X]
HISTAMINE DIHYDROCHLORIDE Histamine 15 [hp_X]
GOLDENSEAL GOLDENSEAL 15 [hp_X]
Iodine IODINE 15 [hp_X]
POTASSIUM DICHROMATE DICHROMATE ION 15 [hp_X]
Potassium Iodide IODIDE ION 15 [hp_X]
MERCURIC IODIDE MERCURIC IODIDE 15 [hp_X]
MERCURY Mercury 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED 15 [hp_X]
LOBARIA PULMONARIA LOBARIA PULMONARIA 15 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
GOLDENSEAL GOLDENSEAL 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4418-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-4418-2 59.14 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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