DRAINER- cynara scolymus, solidago virgaurea, taraxacum officinale, benzoicum acidum, berberis vulgaris, bryonia, cantharis, carduus benedictus, carduus marianus, ceanothus americanus, chelidonium majus, chionanthus virginica, cinchona officinalis, dioscorea villosa, dolichos pruriens, iris versicolor, juniperus communis, nux vomica, ptelea trifoliata, taraxacum officinale, uricum. 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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Drainer 4793P

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination..

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Cynara scolymus 6x, Solidago virgaurea 6x, Taraxacum officinale 6x, Benzoicum acidum 15x, Berberis vulgaris 15x, Bryonia 15x, Cantharis 15x, Carduus benedictus 15x, Carduus marianus 15x, Ceanothus americanus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona officinalis 15x, Dioscorea villosa 15x, Dolichos pruriens 15x, Iris versicolor 15x, Juniperus communis 15x, Nux vomica 15x, Ptelea trifoliata 15x, Taraxacum officinale 15x, Uricum acidum 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

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

DRAINER
cynara scolymus, solidago virgaurea, taraxacum officinale, benzoicum acidum, berberis vulgaris, bryonia, cantharis, carduus benedictus, carduus marianus, ceanothus americanus, chelidonium majus, chionanthus virginica, cinchona officinalis, dioscorea villosa, dolichos pruriens, iris versicolor, juniperus communis, nux vomica, ptelea trifoliata, taraxacum officinale, uricum. pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4793
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE)	CYNARA SCOLYMUS LEAF	6 [hp_X] in 1 g
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	15 [hp_X] in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	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
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	15 [hp_X] in 1 g
CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795)	CENTAUREA BENEDICTA	15 [hp_X] in 1 g
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	15 [hp_X] in 1 g
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	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
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	15 [hp_X] in 1 g
CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E)	CHIONANTHUS VIRGINICUS BARK	15 [hp_X] in 1 g
MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C)	MUCUNA PRURIENS FRUIT TRICHOME	15 [hp_X] in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	15 [hp_X] in 1 g
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL)	JUNIPER BERRY	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
PTELEA TRIFOLIATA BARK (UNII: 5KQR6FTT0D) (PTELEA TRIFOLIATA BARK - UNII:5KQR6FTT0D)	PTELEA TRIFOLIATA BARK	15 [hp_X] in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	15 [hp_X] in 1 g
URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25)	URIC ACID	15 [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:55714-4793-1	30 g 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(55714-4793)