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

Insomulex by

Drug Labeling and Warnings

Insomulex by is a Homeopathic medication manufactured, distributed, or labeled by Hello Life, Inc., King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (per dose)

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

Ambra, Ignatia HPUS

Arsenicum alb 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 HPUS

Each ingredient contains equal volumes of 10X, 30X, and LM1 potencies.  The letters "HPUS" indicate that the components in thsi prodct are officially monographed in the Homeopathic Pharmacopeia of the United States.

Product indications are based on Homeopathic Materia Medica.

Purpose

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

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

Arsenicum alb HPUS....................................................................................................................................................Fear

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 HPUS..............................................................................................................Tiredness during day, staying up late

Each 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 are 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. of 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 (13.6-22.6 kg)         1/2 mL

50+ lbs (22.6+ kg)                 1 mL

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.

DESCRIPTION

• 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: 49726-026-02

INSOMULEX TM

Insomnia Symptom Relief

For temporary relief of symptoms commonly associated with insomnia, including:

• worry
• restless tossing
• light sleeping
• overactive mind

2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49726-026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	10 [hp_X]  in 59 mL
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	10 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 59 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	10 [hp_X]  in 59 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	10 [hp_X]  in 59 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 59 mL
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	10 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X]  in 59 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X]  in 59 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	10 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X]  in 59 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	10 [hp_X]  in 59 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	10 [hp_X]  in 59 mL
HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB)	HYDROCHLORIC ACID	10 [hp_X]  in 59 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	10 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 59 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 59 mL
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	10 [hp_X]  in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49726-026-02	1 in 1 CARTON	08/15/2012
1		59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/2012

Labeler - Hello Life, Inc. (065619378)

Establishment
Name	Address	ID/FEI	Business Operations
Hello Life, Inc.		065619378	relabel(49726-026) , repack(49726-026)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(49726-026)