Pneumostat by Energique, Inc. / Apotheca Company DRUG FACTS:

Pneumostat by

Drug Labeling and Warnings

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

Drug Details [pdf]

PNEUMOSTAT- echinacea (angustifolia), hydrastis canadensis, hypericum perforatum, symphytum officinale, arsenicum album, causticum, kali carbonicum, natrum sulphuricum, phosphorus, pulsatilla (pratensis), silicea 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:

Echinacea (Angustifolia) 3X, Hydrastis Canadensis 3X, Hypericum Perforatum 3X, Symphytum Officinale 3X, Arsenicum Album 12X, Causticum 12X, Kali Carbonicum 12X, Natrum Sulphuricum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Silicea 12X.

INDICATIONS:

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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, consult your health care professional.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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
PNEUMOSTAT
1 fl. oz. (30 ml)

PNEUMOSTAT 
echinacea (angustifolia), hydrastis canadensis, hypericum perforatum, symphytum officinale, arsenicum album, causticum, kali carbonicum, natrum sulphuricum, phosphorus, pulsatilla (pratensis), silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0274
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	12 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI)	PULSATILLA PRATENSIS	12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	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: 44911-0274-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/30/2015	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/30/2015	06/01/2019

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0274) , api manufacture(44911-0274) , label(44911-0274) , pack(44911-0274)

Revised: 5/2019

Document Id: 69b60d35-aced-4778-9018-5fb2459cbc38

34390-5

Set id: 7294bec4-4609-4a87-bc09-c4fcd94ea701

Version: 3

Effective Time: 20190502

 

Energique, Inc.