PMS TONE- angelica archangelica, cimicifuga racemosa, fucus vesiculosus, cuprum metallicum, lac caninum, lachesis mutus 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

Angelica Archangelica 3X, Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Cuprum Metallicum 12X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Pulsatilla 12X, Sepia 12X

INDICATIONS

For temporary relief of fatigue, feelings of anxiety before menstruation, tender breasts, flushes of heat 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 fatigue, feelings of anxiety before menstruation, tender breasts, flushes of heat 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

ENERGIQUE

since 1987

HOMEOPATHIC REMEDY

PMS TONE

1 fl. oz. (30 ml)

PMS Tone

PMS TONE
angelica archangelica, cimicifuga racemosa, fucus vesiculosus, cuprum metallicum, lac caninum, lachesis mutus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0079
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN)	ANGELICA ARCHANGELICA ROOT	3 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X] in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	12 [hp_X] in 1 mL
CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT)	CANIS LUPUS FAMILIARIS MILK	12 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	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:44911-0079-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/01/2013	09/21/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/01/2013	09/21/2022

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0079) , api manufacture(44911-0079) , label(44911-0079) , pack(44911-0079)

Revised: 5/2022

Document Id: 1865d3c2-8911-4abb-b5ca-09b52b601be4

Set id: fe7ae3fc-a980-41aa-b8ea-0ee3944d3666

Version: 3

Effective Time: 20220517

Energique, Inc.