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 pellet
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Sinusitis

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

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

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 pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4419
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Arsenic Triiodide (UNII: 3029988O2T) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Triiodide	15 [hp_X] in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X] in 1 g
Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3)	Helianthemum Canadense	15 [hp_X] in 1 g
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q)	Calcium Sulfide	15 [hp_X] in 1 g
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3)	Histamine Dihydrochloride	15 [hp_X] in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV)	Goldenseal	15 [hp_X] in 1 g
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	15 [hp_X] in 1 g
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V)	Potassium Dichromate	15 [hp_X] in 1 g
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q)	Iodide Ion	15 [hp_X] in 1 g
Mercuric Iodide (UNII: R03O05RB0P) (Mercuric Iodide - UNII:R03O05RB0P)	Mercuric Iodide	15 [hp_X] in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	15 [hp_X] in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W)	Phosphorus	15 [hp_X] in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	15 [hp_X] in 1 g
Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO)	Schoenocaulon Officinale Seed	15 [hp_X] in 1 g
Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T)	Lobaria Pulmonaria	15 [hp_X] in 1 g
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172)	Verbascum Thapsus	15 [hp_X] in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
Sucrose (UNII: C151H8M554)

#	Item Code	Package Description
Packaging
1	NDC:55714-4419-1	28.35 g in 1 BOTTLE, GLASS
2	NDC:55714-4419-2	56.7 g in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4419)