ALLERSTAT I (chelidonium majus, echinacea (angustifolia), gentiana lutea, arsenicum album, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus, pulsatilla- pratensis liquid

Allerstat by

Drug Labeling and Warnings

Allerstat by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each drop): 16.62% of Arsenicum Album 12X, Carbo Vegetabilis 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X; 0.10% of Chelidonium Majus 3X, Echinacea (Angustifolia) 3X, Gentiana Lutea 3X.

INDICATIONS:

May temporarily relieve digestive symptoms, such as indigestion with flatulence and bloating and loss of weight, associated with problem foods.**

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

WARNINGS:

If pregnant or breastfeeding, 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 a cool, dry place.

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.

DIRECTIONS:

Adults and children 5 to 10 drops 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 digestive symptoms, such as indigestion with flatulence and bloating and loss of weight, associated with problem foods.**

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

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
ALLERSTAT I
1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

ALLERSTAT  I
chelidonium majus, echinacea (angustifolia), gentiana lutea, arsenicum album, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus, pulsatilla (pratensis) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0268
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS)	GENTIANA LUTEA ROOT	3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	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: 44911-0268-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/20/2015

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0268) , api manufacture(44911-0268) , label(44911-0268) , pack(44911-0268)