DailyMed - DETOXIFIER- uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom.,ptelea,taraxacum, carduus mar., cynara scolymus, solidago pellet

NDC Code(s): 55714-2419-1, 55714-2419-2
Packager: Newton Laboratories, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated November 24, 2020

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INDICATIONS & USAGE SECTION
Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.
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DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) at bedtime or as directed by a health professional. Under age 2, crush or dissolve pelles in pirified water ...

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) at bedtime or as directed by a health professional. Under age 2, crush or dissolve pelles in pirified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x, Benzoicum ac. 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus ben. 10x, Carduus mar. 10x, Ceanothus 10x, Chelidonium maj. 10x ...

Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x, Benzoicum ac. 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus ben. 10x, Carduus mar. 10x, Ceanothus 10x, Chelidonium maj. 10x, Chionanthus 10x, Cinchona 10x, Dioscorea 10x, Dolichos 10x, Iris vers. 10x, Juniperus com. 10x, Ptelea 10x, Taraxacum 10x, Nux vom. 15, Uricum ac. 15x.
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OTC - PURPOSE SECTION
Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.
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INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose (lactose-free) pellets.

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose (lactose-free) pellets.
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QUESTIONS SECTION
newtonlabs.net - Questions ? 800.448.7256 - Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

newtonlabs.net - Questions ? 800.448.7256

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

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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 ...

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.

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OTC - PREGNANCY OR BREAST FEEDING SECTION
If - pregnant or breast-feeding, ask a doctor before use.

If pregnant or breast-feeding, ask a doctor before use.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.

Keep out of reach of children.
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PACKAGE LABEL

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INGREDIENTS AND APPEARANCE

Product Information

DETOXIFIER uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom.,ptelea,taraxacum, carduus mar., cynara scolymus, solidago pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2419
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	10 [hp_X] in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	10 [hp_X] in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X] in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	10 [hp_X] in 1 g
CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795)	CENTAUREA BENEDICTA	10 [hp_X] in 1 g
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	10 [hp_X] in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	10 [hp_X] in 1 g
CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E)	CHIONANTHUS VIRGINICUS BARK	10 [hp_X] in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X] in 1 g
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	10 [hp_X] in 1 g
MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C)	MUCUNA PRURIENS FRUIT TRICHOME	10 [hp_X] in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	10 [hp_X] in 1 g
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL)	JUNIPER BERRY	10 [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	10 [hp_X] in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	10 [hp_X] in 1 g
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	10 [hp_X] in 1 g
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE)	CYNARA SCOLYMUS LEAF	6 [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
URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25)	URIC ACID	15 [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:55714-2419-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019
2	NDC:55714-2419-2	50 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019	08/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2419)

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Published Date (What is this?)	Version	Files
Nov 25, 2020	3 (current)	download
Sep 17, 2019	2	download

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	NDC
1	55714-2419-1
2	55714-2419-2

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