GLUTEN DETOX (barley (grain), carbo vegetabilis, cinchona officinalis, gluten, glyphosate, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, nux vomica, oat (grain), pancreas suis, pulsatilla (vulgaris), rye (grain), wheat- grain liquid

Gluten Detox by

Drug Labeling and Warnings

Gluten Detox by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each spray) 7.14% of Barley (Grain) 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 6X, Gluten 15X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 200C, Natrum Muriaticum 30C, Nux Vomica 30C, Oat (Grain) 12X, Pancreas Suis 6X, Pulsatilla (Vulgaris) 200C, Rye (Grain) 12X, Wheat (Grain) 12X.

INDICATIONS:

May temporarily relieve symptoms related to reactions to gluten, such as:

bloating

brain fog

poor digestion

abdominal pain

alternating constipation and diarrhea**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

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

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: Spray twice under the tongue three times per day.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

May temporarily relieve symptoms related to reactions to gluten, such as:

bloating

brain fog

poor digestion

abdominal pain

alternating constipation and diarrhea**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

DIST. BY

LIDDELL LABORATORIES INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL

LABORATORIES

EST. 1994

DETOX

58 GD

Gluten Detox

May relieve symptoms

of bloating, poor digestion,

abdominal pain, and brain fog

HOMEOPATHIC

DOCTOR FORMULATED

Readily absorbed. Safe.

No known side effects. Easy to use

1.0 FL. OZ. (30 ml)

INGREDIENTS AND APPEARANCE

GLUTEN DETOX 
barley (grain), carbo vegetabilis, cinchona officinalis, gluten, glyphosate, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, nux vomica, oat (grain), pancreas suis, pulsatilla (vulgaris), rye (grain), wheat (grain) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R)	BARLEY	12 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X]  in 1 mL
WHEAT GLUTEN (UNII: 1534K8653J) (WHEAT GLUTEN - UNII:1534K8653J)	WHEAT GLUTEN	15 [hp_X]  in 1 mL
GLYPHOSATE (UNII: 4632WW1X5A) (GLYPHOSATE - UNII:4632WW1X5A)	GLYPHOSATE	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	200 [hp_C]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C]  in 1 mL
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	12 [hp_X]  in 1 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	200 [hp_C]  in 1 mL
RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X)	RYE	12 [hp_X]  in 1 mL
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y)	WHEAT	12 [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: 50845-0234-2	1 in 1 CARTON	05/23/2017
1	NDC: 50845-0234-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/23/2017

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0234) , api manufacture(50845-0234) , label(50845-0234) , pack(50845-0234)