Hendel Insomnia Relief

SPL v4

SPL

SPL Set ID 565298ba-ce51-48d0-b6a4-d4d6c40f2b9e

Route

ORAL

Published

Effective Date 2023-02-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Passiflora Incarnata Flowering Top (2 [hp_X]) Ambergris (6 [hp_X]) Scutellaria Lateriflora (12 [hp_X]) Valeric Acid Anamirta Cocculus Seed Arabica Coffee Bean

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2016-05-31

Description

If pregnant or breast-feeding, ask a health professional before use . Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

Purpose

Insomnia Relief

Medication Information

Purpose

Insomnia Relief

Description

Uses

For the temporary relief of:

• Occasional Nervous Restlessness

• Occasional Sleeplessness

• Frequent Awakening

Section 51945-4

Add image transcription here...

Warnings

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

Directions

Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed

by a physician.

Active Ingredient

Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X

Inactive Ingredient

Lactose, Magnesium stearate

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Structured Label Content

Uses

For the temporary relief of:

• Occasional Nervous Restlessness

• Occasional Sleeplessness

• Frequent Awakening

Section 51945-4 (51945-4)

Add image transcription here...

Purpose (PURPOSE)

Insomnia Relief

Warnings (WARNINGS)

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

Directions

Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed

by a physician.

Active Ingredient (ACTIVE INGREDIENT)

Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X

Inactive Ingredient (INACTIVE INGREDIENT)

Lactose, Magnesium stearate

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Advanced Ingredient Data

[{"name": "PASSIFLORA INCARNATA FLOWERING TOP", "unii": "CLF5YFS11O", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "AMBERGRIS", "unii": "XTC0D02P6C", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "SCUTELLARIA LATERIFLORA", "unii": "7BP4DH5PDC", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "VALERIC ACID", "unii": "GZK92PJM7B", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ANAMIRTA COCCULUS SEED", "unii": "810258W28U", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of: • Occasional Nervous Restlessness • Occasional Sleeplessness • Frequent Awakening", "51945-4": "Add image transcription here...", "PURPOSE": "Insomnia Relief", "WARNINGS": "If pregnant or breast-feeding, ask a health professional before use . Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.", "Directions": "Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed by a physician.", "ACTIVE INGREDIENT": "Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X", "INACTIVE INGREDIENT": "Lactose, Magnesium stearate", "KEEP OUT OF REACH OF CHILDREN": "KEEP OUT OF REACH OF CHILDREN"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:59.277311 · Updated: 2026-03-14T23:16:02.199714