INSOMULEX - horse chestnut, ambergris, zinc, avena sativa flowering top, barium carbonate, camphor (natural), cinchona officinalis bark, anamirta cocculus seed, arabica coffee bean, cypripedium parvifolum root, gelsemium sempervirens root, hyoscyamus niger, strychnos ignatii seed, potassium bromide, potassium phosphate, dibasic, magnesium carbonate, hydrochloric acid, sodium phosphate, dibasic, heptahydrate, passiflora incarnata flowering top, pulsatilla vulgaris, scutellaria lateriflora, sulfur and valerian liquid
Ionx Holdings d/b/a HelloLife

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients (per dose)

Aesculus hipp, flos, Baryta carb,
Cypripedium, Hyoscyamus,
Mag carb, Sulphur HPUS

Ambra, Ignatia HPUS

Avena, Cocculus, Coffea cruda,
Gelsemium, Kali phos HPUS

Camphora, Kali brom,
Passiflora, Scutellaria HPUS

Cinchona HPUS

Muriaticum ac, Valeriana,
Zinc met HPUS

Nat phos, Pulsatilla HPUS

Purpose

Aesculus hipp, flos, Baryta carb,
Cypripedium, Hyoscyamus,
Mag carb, Sulphur HPUS……………………………Trouble sleeping

Ambra, Ignatia HPUS…………………..…………….Worry

Avena, Cocculus, Coffea cruda,
Gelsemium, Kali phos HPUS………………………Nervous Exhaustion

Camphora, Kali brom,
Passiflora, Scutellaria HPUS……………………….Restlessness

Cinchona HPUS………….………………………………Anxiousness

Muriaticum ac, Valeriana,
Zinc met HPUS…………………………………….…….Tossing and turning

Nat phos, Pulsatilla HPUS……………………………Tiredness during day, staying up late

Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Indications based on Homeopathic Materia Medica.

Uses

For the temporary relief of symptoms commonly associated with insomnia, including:
•    worry
•    restless tossing
•    light sleeping
•    overactive mind

Warnings

Ask a doctor before use if

• you are taking any other medications
• you have a medical condition

When using this product,

use only as directed.

Stop use and ask a doctor if

symptoms persist or worsen.

If pregnant or breast-feeding,

use only on the advice of a physician.

Keep out of the reach of children.

Directions

• add recommended dosage into 8-12 oz. purified (non-chlorinated) water and drink, or dispense Insomulex directly into mouth.

• for optimal benefit, use Insomulex prior to bedtime, naptime, or returning to either after a disruption.

DOSAGE BY WEIGHT

30-50 lbs                   1/2 mL
(13.6-22.6 kg)

50+ lbs                      1 mL
(22.6+ kg)

Other Information

•    do not use if tamper seal is broken
•    store in a cool, dry place
•    product must not come in contact with metal
•    do not store next to electrical devices or appliances

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions or comments?

You can email us at info@hellolife.net or give us a call toll-free at
1.800.875.0850. Monday through Friday 9am-5pm

•    30-day supply
•    dropper included
•    Insomulex is made without alcohol or sugar. No gluten added.

Mftd for: HelloLife, LLC
4460 44th St. SE, Ste. C-600
Grand Rapids, MI 49512

FDA Pharmaceutical Establishment
#1053442, #3009727070
www.insomulex.com

Principal Display Panel

NDC 49726-036-02

INSOMULEX™

Insomnia Symptom Relief
For temporary relief of symptoms commonly associated with insomnia, including:
•    worry
•    restless tossing
•    light sleeping
•    overactive mind

2 FL OZ (59mL)
Homeopathic (OTC) Medicine

Insomulex Carton

INSOMULEX
aesculus hipp, flos, ambra, avena, baryta carb, camphora, cinchona, cocculus, coffea cruda, cypripedium, gelsemium, hyoscyamus, ignatia, kali brom, kali phos, mag carb, muriaticum ac, nat phos, passiflora, pulsatilla, scutellaria, sulphur, valeriana, zinc met liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49726-036
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HORSE CHESTNUT (HORSE CHESTNUT)	HORSE CHESTNUT	10 [hp_X] in 59 mL
AMBERGRIS (AMBERGRIS)	AMBERGRIS	10 [hp_X] in 59 mL
ZINC (ZINC)	ZINC	10 [hp_X] in 59 mL
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP)	AVENA SATIVA FLOWERING TOP	10 [hp_X] in 59 mL
BARIUM CARBONATE (BARIUM CATION)	BARIUM CARBONATE	10 [hp_X] in 59 mL
CAMPHOR (NATURAL) (CAMPHOR (NATURAL))	CAMPHOR (NATURAL)	10 [hp_X] in 59 mL
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK)	CINCHONA OFFICINALIS BARK	10 [hp_X] in 59 mL
ANAMIRTA COCCULUS SEED (ANAMIRTA COCCULUS SEED)	ANAMIRTA COCCULUS SEED	10 [hp_X] in 59 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN)	ARABICA COFFEE BEAN	10 [hp_X] in 59 mL
CYPRIPEDIUM PARVIFOLUM ROOT (CYPRIPEDIUM PARVIFOLUM ROOT)	CYPRIPEDIUM PARVIFOLUM ROOT	10 [hp_X] in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X] in 59 mL
HYOSCYAMUS NIGER (HYOSCYAMUS NIGER)	HYOSCYAMUS NIGER	10 [hp_X] in 59 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED)	STRYCHNOS IGNATII SEED	10 [hp_X] in 59 mL
POTASSIUM BROMIDE (BROMIDE ION)	POTASSIUM BROMIDE	10 [hp_X] in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION)	POTASSIUM PHOSPHATE, DIBASIC	10 [hp_X] in 59 mL
MAGNESIUM CARBONATE (CARBONATE ION)	MAGNESIUM CARBONATE	10 [hp_X] in 59 mL
HYDROCHLORIC ACID (HYDROCHLORIC ACID)	HYDROCHLORIC ACID	10 [hp_X] in 59 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	10 [hp_X] in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X] in 59 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS)	PULSATILLA VULGARIS	10 [hp_X] in 59 mL
SCUTELLARIA LATERIFLORA (SCUTELLARIA LATERIFLORA)	SCUTELLARIA LATERIFLORA	10 [hp_X] in 59 mL
SULFUR (SULFUR)	SULFUR	10 [hp_X] in 59 mL
VALERIAN (VALERIAN)	VALERIAN	10 [hp_X] in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
WATER

Packaging
#	Item Code	Package Description
1	NDC:49726-036-02	1 in 1 CARTON
1		59 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/25/2013

Labeler - Ionx Holdings d/b/a HelloLife (021312334)

Registrant - Ionx Holdings d/b/a HelloLife (021312334)

Establishment
Name	Address	ID/FEI	Business Operations
HelloLife, Inc.		966832995	relabel(49726-036), repack(49726-036)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(49726-036)

Revised: 11/2012

Document Id: ff349e76-a2cb-4668-9910-dafd9373899c

Set id: 377bd8f8-be64-452d-b838-67e103f5b31c

Version: 1

Effective Time: 20121122

Ionx Holdings d/b/a HelloLife