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
Liddell Laboratories, Inc.

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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Drug Facts:

ACTIVE INGREDIENTS:

(in each spray) 7.69% of Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 6X, Cypripedium pubescens 3X, Humulus lupulus 3X, Hypericum perforatum 6X, Kali phosphoricum 12X, Melatonin 6X, Melissa officinalis 3X, Natrum muriaticum 30C, Passiflora incarnata 2X, Valeriana officinalis 2X.

(Symptom relief for occasional sleeplessness**)

USES:

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety
restlessness
stress
caffeine sensitivity**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

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, 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.

OTHER INFORMATION: Store at room temperature.

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.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

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.

USES:

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety
restlessness
stress
caffeine sensitivity**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

QUESTIONS:

DIST. BY:

LIDDELL LABORATORIES

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL
LABORATORIES

EST. 1994

32Ins
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)

Insomnia lbl

Insomnia ctn

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:50845-0108
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
CHAMOMILLA (UNII: 2Z4LRR776S) (CHAMOMILLA - UNII:2Z4LRR776S)	CHAMOMILLA	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	3 [hp_X] in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	12 [hp_X] in 1 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X] in 1 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50845-0108-2	1 in 1 CARTON	09/13/2016	04/10/2024
1	NDC:50845-0108-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/04/2012	04/10/2024

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50845-0108) , api manufacture(50845-0108) , pack(50845-0108) , label(50845-0108)

Revised: 6/2022

Document Id: 54f9955d-1e43-4ea3-bcf4-8a26f0647cc9

Set id: a12c7f46-d73b-40d1-bdfa-970ec45bcfe4

Version: 11

Effective Time: 20220630

Liddell Laboratories, Inc.