I-WAKER- apis mellifica, echinacea, hydrastis canadensis, thuja occidentalis, aconitum napellus, agaricus muscarius, allium sativum, aloe, arnica montana, arsenicum album, baptisia tinctoria, belladonna, bryonia, calcarea carbonica, calendula officinalis, capsicum annuum, carduus marianus, hepar sulphuris calcareum, iodium, lachesis mutus, lycopodium clavatum, mercurius vivus, nux vomica, phosphorus, pulsatilla, rhus toxicodendron, salvia officinalis, selenium metallicum, taraxacum officinale, tarentula hispana, liquid

I-Waker by

Drug Labeling and Warnings

I-Waker by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as hypersensitivity, debility, glandular swellings, infections and inflammation.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Thuja occidentalis 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium sativum 15x, Aloe 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calcarea carbonica 15x, Calendula officinalis 15x, Capsicum annuum 15x, Carduus marianus 15x, Hepar sulphuris calcareum 15x, Iodium 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salvia officinalis 15x, Selenium metallicum 15x, Taraxacum officinale 15x, Tarentula hispana 15x, Zincum metallicum 15x, Zingiber officinale 15x, Anthracinum 16x, Azadirachta indicia 16x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as hypersensitivity, debility, glandular swellings, infections and inflammation.

INACTIVE INGREDIENT SECTION

Inactive 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 SECTION

Keep out of reach of children.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

I-WAKER 
apis mellifica, echinacea, hydrastis canadensis, thuja occidentalis, aconitum napellus, agaricus muscarius, allium sativum, aloe, arnica montana, arsenicum album, baptisia tinctoria, belladonna, bryonia, calcarea carbonica, calendula officinalis, capsicum annuum, carduus marianus, hepar sulphuris calcareum, iodium, lachesis mutus, lycopodium clavatum, mercurius vivus, nux vomica, phosphorus, pulsatilla, rhus toxicodendron, salvia officinalis, selenium metallicum, taraxacum officinale, tarentula hispana, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-4838
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	15 [hp_X]  in 1 mL
INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W)	INFLUENZA B VIRUS	30 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X]  in 1 mL
AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI)	AZADIRACHTA INDICA BARK	16 [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
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X]  in 1 mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N)	BACILLUS ANTHRACIS IMMUNOSERUM RABBIT	16 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	15 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	15 [hp_X]  in 1 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT)	LYCOSA TARANTULA	15 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X]  in 1 mL
INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E)	INFLUENZA A VIRUS	30 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X]  in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	15 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	15 [hp_X]  in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	15 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	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
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	15 [hp_X]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	15 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	15 [hp_X]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	15 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	15 [hp_X]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	15 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4838-2	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

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

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4838)