Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 49726-026-02 - Packager: Hello Life, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 26, 2018
If you are a consumer or patient please visit this version.
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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.
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Purpose
Aesculus hipp, flos, Baryta carb, Cypripedium, Hyoscyamus, Mag carb, Sulphur HPUS.....................................Trouble sleeping
Ambra, Ignatia HPUS...................................................................................................................................................WorryArsenicum 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
- Warnings
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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
- Inactive Ingredients
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- DESCRIPTION
- Principal Display Panel
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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 liquidProduct 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)