SINU-S- echinacea, hydrastis canadensis, arsenicum iodatum, bryonia, cistus canadensis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, iodium, kali bichromicum, kali iodatum, mercurius iodatus ruber, mercurius vivus, nux vomica, phosphorus pulsatilla, sabadilla, sticta , verbascum thapsus, sinusitisinum liquid
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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Sinu-S 4778L

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 - 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%.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PACKAGE LABEL

package label

SINU-S
echinacea, hydrastis canadensis, arsenicum iodatum, bryonia, cistus canadensis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, iodium, kali bichromicum, kali iodatum, mercurius iodatus ruber, mercurius vivus, nux vomica, phosphorus pulsatilla, sabadilla, sticta , verbascum thapsus, sinusitisinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4778
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3)	HELIANTHEMUM CANADENSE	15 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	15 [hp_X] in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	15 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	15 [hp_X] in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	15 [hp_X] in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	15 [hp_X] in 1 mL
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P)	MERCURIC IODIDE	15 [hp_X] in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X] in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	15 [hp_X] in 1 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5)	SINUSITISINUM	16 [hp_X] in 1 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	15 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4778-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4778)