INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations,

DOSAGE & ADMINISTRATION SECTION

Ages 12 and up, take 6 pelletsby mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Apis mellifica 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Blatta orientalis 15x, Bromium 15x, Bryonia 15x, Candida albicans 15x, Carduus benedictus 15x, Cat hair 15x, Chelidonium majus 15x, Cinchona officinalis 15x, Dog hair 15x, Histaminum hydrochloricum 15x, House dust 15x, Ipecacuanha 15x, Lycopodium clavatum 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Silicea 15x, Ustilago maidis 15x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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 SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

DUST-MOLD-DANDER
iris versicolor, solidago virgaurea, antimonium crudum, apis mellifica, arsenicum album, baptisia tinctoria, blatta orientalis, bromium, bryonia, candida albicans, carduus benedictus, cat hair, chelidonium majus, cinchona officinalis, dog hair, histaminum hydrochloricum, house dust, ipecacuanha, lycopodium clavatum, nux vomica, podophyllum peltatum, rhus toxicodendron, secale cornutum, silicea, ustilago maidis, torula cerevisiae. pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2423
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98)	HOUSE DUST	15 [hp_X] in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	6 [hp_X] in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY TRISULFIDE	15 [hp_X] in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	15 [hp_X] in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 g
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X] in 1 g
BLATTA ORIENTALIS (UNII: 535787266D) (BLATTA ORIENTALIS - UNII:535787266D)	BLATTA ORIENTALIS	15 [hp_X] in 1 g
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	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
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	15 [hp_X] in 1 g
CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795)	CENTAUREA BENEDICTA	15 [hp_X] in 1 g
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96)	FELIS CATUS HAIR	15 [hp_X] in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X] in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X] in 1 g
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR)	CANIS LUPUS FAMILIARIS HAIR	15 [hp_X] in 1 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	15 [hp_X] in 1 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	15 [hp_X] in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	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
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	15 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 g
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	15 [hp_X] in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X] in 1 g
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG)	USTILAGO MAYDIS	15 [hp_X] in 1 g
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H)	SACCHAROMYCES CEREVISIAE	16 [hp_X] in 1 g
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	6 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2423-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2423)

Dust 2423P