FLUTONE- baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, arsenicum album, bryonia, eupatorium perfoliatum 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.

----------

Drug Facts

ACTIVE INGREDIENTS

Baptisia Tinctoria 3X, Echinacea 3X, Hydrastis Canadensis 3X, Phytolacca Decandra 3X, Arsenicum Album 12X, Bryonia 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Ipecacuanha 12X, Rhus Toxicodendron

INDICATIONS

For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headache.

**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.

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.

INACTIVE INGREDIENTS

Demineralized water, 20% Ethanol.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS AND USAGE

For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headache.

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

QUESTIONS

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

since 1987

HOMEOPATHIC REMEDY

FLUTONE

1 fl. oz. (30 ml)

Flutone

FLUTONE
baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, arsenicum album, bryonia, eupatorium perfoliatum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0080
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X] in 1 mL
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
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X] in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	12 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X] in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44911-0080-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/23/2013	08/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/23/2013	08/27/2020

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0080) , api manufacture(44911-0080) , label(44911-0080) , pack(44911-0080)

Revised: 6/2020

Document Id: f2ba51b9-00fb-4c70-aa05-ea4afb32a8d6

Set id: e31e1677-b466-4506-8ebd-b1866408501c

Version: 3

Effective Time: 20200616

Energique, Inc.