INSOMNIA- aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis spray

Insomnia by

Drug Labeling and Warnings

Insomnia by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each spray) 7.69% of Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 8X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.

USES:

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety, restlessness, stress, and caffeine sensitivity**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

See box.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist for more than 7 days, worsen, or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

KEEP OUT OF REACH OF CHILDREN.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: Two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness.

Children under 12: Consult a doctor prior to use.

USES:

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety, restlessness, stress, and caffeine sensitivity**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

DIST. BY:

LIDDELL LABORATORIES INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL
LABORATORIES

EST. 1994

32 Ins
Insomnia

May relieve symptoms associated
with occasional sleeplessness
caused by anxiety, restlessness,
stress, or caffeine sensitivity.

HOMEOPATHIC
DOCTOR FORMULATED

Readily absorbed. Safe.
No known side effects. Easy to use.

1.0 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

INSOMNIA 
aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0272
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2)	AQUILEGIA VULGARIS	2 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	2 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	8 [hp_X]  in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X]  in 1 mL
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	6 [hp_X]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	12 [hp_X]  in 1 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X]  in 1 mL
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS WHOLE	3 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	2 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50845-0272-2	1 in 1 CARTON	12/23/2020
1	NDC: 50845-0272-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/23/2020

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0272) , api manufacture(50845-0272) , label(50845-0272) , pack(50845-0272)