COLOSTAT- rhamnus purshiana, spigelia anthelmia, taraxacum officinale, cajuputum, hydrastis canadensis, alumina, cina, cinchona officinalis, lycopodium clavatum, magnesia phosphorica, mandragora officinarum, nux vomica liquid 
Energique, 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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Drug Facts:

ACTIVE INGREDIENTS:

(in each drop): 14.21% of Alumina 12X, Cina 12X, Cinchona Officinalis 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X; 0.10% of Cajuputum 6X, Mandragora Officinarum 12X, Rhamnus Purshiana 3X, Spigelia Anthelmia 3X, Taraxacum Officinale 3X.

INDICATIONS:

May temporarily relieve flatulence associated with constipation.**

**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 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 flatulence associated with constipation.**

**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
COLOSTAT
1 fl. oz. (30 ml)

Colostat

COLOSTAT 
rhamnus purshiana, spigelia anthelmia, taraxacum officinale, cajuputum, hydrastis canadensis, alumina, cina, cinchona officinalis, lycopodium clavatum, magnesia phosphorica, mandragora officinarum, nux vomica liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK3 [hp_X]  in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37) CAJUPUT OIL6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE12 [hp_X]  in 1 mL
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP12 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
MANDRAGORA OFFICINARUM ROOT (UNII: I2XCB174VB) (MANDRAGORA OFFICINARUM ROOT - UNII:I2XCB174VB) MANDRAGORA OFFICINARUM ROOT12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0411-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/30/2016
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0411) , api manufacture(44911-0411) , label(44911-0411) , pack(44911-0411)

Revised: 10/2019
Document Id: d0286b12-50d0-40d5-9ee1-74ac5ba42be5
Set id: 89c86e7b-304c-43a6-81e7-373d95c9fac1
Version: 5
Effective Time: 20191002
 
Energique, Inc.