INSOMNIA HP- arsenic trioxide, arabica coffee bean, potassium carbonate, strychnos nux-vomica seed, passiflora incarnata top, sepia officinalis juice, valerian and magnesium carbonate liquid
Apotheca Company

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:

Arsenicum album 30X, Coffea cruda 30X, Kali carbonicum 30X, Magnesia carbonica 30X, Nux vomica 30X, Passiflora incarnata 30X, Sepia 30X, Valeriana officinalis 30X.

INDICATIONS:

For temporary relief of sleeplessness.

WARNINGS:

If pregnant or breast-feeding, ask a health care 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:

10 Drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol

INDICATIONS:

For temporary relief of sleeplessness.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE DISPLAY LABEL:

BioActive Homeopathic

INSOMNIA-HP

1 FL OZ (30 ml)

Insomnia-HP

INSOMNIA HP
arsenicum album, coffea cruda, kali carbonicum, magnesia carbonica, nux vomica, passiflora incarnata, sepia, valeriana officinalis, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0331
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	30 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X] in 1 mL
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	30 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	30 [hp_X] in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	30 [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:57520-0331-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/26/2010	04/29/2015

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0331) , api manufacture(57520-0331) , label(57520-0331) , pack(57520-0331)

Revised: 8/2015

Document Id: ff0bd0bd-4210-4438-8f59-15ad9ea6b87c

Set id: 1fac48cc-c9b6-42e5-939e-74c2ccdc1e54

Version: 3

Effective Time: 20150806

Apotheca Company