INSOMULEX  - horse chestnut, ambergris, arsenic trioxide, 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, valerian and zinc 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.

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Insomulex has been (OTC) formulated to temporarily relieve symptoms of restlessness, inability to fall asleep and sleeplessness associated with restless tossing, light sleeping, overactive mind, and worry.

Uses:

to temporarily relieve symptoms of restlessness, inability to fall asleep and sleeplessness associated with restless tossing, light sleeping, overactive mind, and worry.

Warnings:

If symptoms persist or worsen, seek advice of a physician.  If pregnant or nursing, take only on advice of physician.

Keep out of reach of children.

Active Ingredients:

Aesculus hipp, flos HPUS, Ambra HPUS, Arsenicum alb HPUS, Avena HPUS, Baryta carb HPUS, Camphora HPUS, Cinchona HPUS, Cocculus HPUS, Coffea cruda HPUS, Cypripedium HPUS, Gelsemium HPUS, Hyoscyamus HPUS, Ignatia HPUS, Kali brom HPUS, Kali phos HPUS, Mag carb HPUS, Muriaticum ac HPUS, Nat phos HPUS, Passiflora HPUS, Pulsatilla HPUS, Scutellaria HPUS, Sulphur HPUS, Valeriana HPUS, Zinc met HPUS

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

Inactive Ingredients:

Citric acid, Potassium sorbate, Purified ionized mineral water

Storage and Handling:

Product must not come in contact with metal.  Do not store next to electrical devices or appliances.  Store in cool, dry place.

Directions:

Add recommended dosage to 8-12 oz non-chlorinated water and drink; or, dispense dosage directly into mouth. See recommended dosage below.  Under 18, consult your health care provider.

Recommended Dosage by Weight: 30-50 lbs (13.6-22.6 kg) 1/2 mL twice per day; 50+ lbs (22.6+ kg) 1 mL twice per day

DO NOT USE IF TAMPER SEAL IS BROKEN.

Manufactured for: HelloLife, Inc. Grand Rapids MI 49512
FDA Pharmaceutical Establishment #1053442

Manufactured in the USA
www.hellolife.net

Insomulex contains no alcohol or sugar; no gluten added.

Principal Display Panel:

Insomulex

Insomnia Symptom Relief

Homeopathic (OTC) Medicine

2 FL OZ (59 mL)

Insomulex label


INSOMULEX 
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, pulsatilla, scutellaria, sulphur, valeriana, zinc met liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-026
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HORSE CHESTNUT (HORSE CHESTNUT) HORSE CHESTNUT10 [hp_X]  in 59 mL
AMBERGRIS (AMBERGRIS) AMBERGRIS10 [hp_X]  in 59 mL
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
BARIUM CARBONATE (BARIUM CATION) BARIUM CARBONATE10 [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 BARK10 [hp_X]  in 59 mL
ANAMIRTA COCCULUS SEED (ANAMIRTA COCCULUS SEED) ANAMIRTA COCCULUS SEED10 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN10 [hp_X]  in 59 mL
CYPRIPEDIUM PARVIFOLUM ROOT (CYPRIPEDIUM PARVIFOLUM ROOT) CYPRIPEDIUM PARVIFOLUM ROOT10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER10 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
POTASSIUM BROMIDE (POTASSIUM CATION) POTASSIUM BROMIDE10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE10 [hp_X]  in 59 mL
HYDROCHLORIC ACID (HYDROCHLORIC ACID) HYDROCHLORIC ACID10 [hp_X]  in 59 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE10 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 59 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
SCUTELLARIA LATERIFLORA (SCUTELLARIA LATERIFLORA) SCUTELLARIA LATERIFLORA10 [hp_X]  in 59 mL
SULFUR (SULFUR) SULFUR10 [hp_X]  in 59 mL
VALERIAN (VALERIAN) VALERIAN10 [hp_X]  in 59 mL
ZINC (ZINC) ZINC10 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
POTASSIUM SORBATE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:49726-026-0259 mL in 1 BOTTLE, DROPPERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/2012

Labeler - Ionx Holdings d/b/a HelloLife (021312334)
Registrant - Ionx Holdings d/b/a HelloLife (021312334)
Establishment
NameAddressID/FEIOperations
HelloLife, Inc.966832995relabel, repack
Establishment
NameAddressID/FEIOperations
King Bio Inc.617901350manufacture

Revised: 08/2012 Ionx Holdings d/b/a HelloLife