drug facts:

drug facts:
SPL v1
SPL
SPL Set ID c6b867b6-74d9-4725-90d7-7d5d1fe61121
Route
oral
Published
Effective Date 2023-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alfalfa (4 [hp_X]) ginger (6 [hp_X]) cinchona officinalis bark (12 [hp_X]) goldenseal (16 [hp_X]) barley activated charcoal glyphosate lycopodium clavatum spore chloride ion strychnos nux-vomica seed oat anemone pulsatilla rye wheat wheat gluten
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2023-04-05

Purpose

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 6.67% of Alfalfa 4X, Barley 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat 12X, Pulsatilla 12X, Rye 12X, Wheat 12X, Zingiber Officinale 4X.


Medication Information

Purpose

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 6.67% of Alfalfa 4X, Barley 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat 12X, Pulsatilla 12X, Rye 12X, Wheat 12X, Zingiber Officinale 4X.

Purpose:

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

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

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions:

Adults and children 5 to 10 orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

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

Active Ingredients:

(in each drop): 6.67% of Alfalfa 4X, Barley 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat 12X, Pulsatilla 12X, Rye 12X, Wheat 12X, Zingiber Officinale 4X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GLUTENSTAT

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

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

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 6.67% of Alfalfa 4X, Barley 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat 12X, Pulsatilla 12X, Rye 12X, Wheat 12X, Zingiber Officinale 4X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GLUTENSTAT

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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