Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 18c15f17-1a16-4595-9d23-20353363cd72
Route
ORAL
Published
Effective Date 2020-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aquilegia Vulgaris (2 [hp_X]) Avena Sativa Flowering Top (6 [hp_X]) Matricaria Chamomilla (8 [hp_X]) Arabica Coffee Bean (3 [hp_X]) Cypripedium Parviflorum Var. Pubescens Root (12 [hp_X]) Hops (30 [hp_C]) Hypericum Perforatum Phosphate Ion Melatonin Melissa Officinalis Chloride Ion Passiflora Incarnata Flowering Top Valerian
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-12-23

Description

(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.


Medication Information

Description

(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.

Questions:

DIST. BY:

LIDDELL LABORATORIES INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

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.

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.

Inactive Ingredients:

Organic alcohol 20% v/v, Purified water.

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)

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.


Structured Label Content

Uses: (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: (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.

Questions: (QUESTIONS:)

DIST. BY:

LIDDELL LABORATORIES INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

Directions: (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.

Active Ingredients: (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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Organic alcohol 20% v/v, Purified water.

Package Label Display: (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)

Keep Out of Reach of Children. (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.


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Raw Label Data

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