Hyland's Sleep

SPL v4

SPL

SPL Set ID 8ad9775f-367c-45c9-890d-69a3734965f1

Route

ORAL

Published

Effective Date 2014-09-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hyoscyamus Niger (6 [hp_X]) Strychnos Ignatii Seed (3 [hp_X]) Phosphate Ion

Inactive Ingredients

Acacia Lactose

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2014-11-05

Description

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Indications and Usage

 Temporarily relieves symptoms of occasional sleeplessness due to:  anxiousness  worry  wakefulness  nervousness

Dosage and Administration

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Medication Information

Indications and Usage

 Temporarily relieves symptoms of occasional

sleeplessness due to:

 anxiousness  worry

 wakefulness  nervousness

Dosage and Administration

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Description

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Uses

■ Temporarily relieves symptoms of occasional sleeplessness due to:

■ anxiousness ■ worry

■ wakefulness ■ nervousness

Section 34088-5

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Section 42229-5

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 50565-1

Keep this and all medications out of the reach of children.

Section 50566-9

Stop use and consult a physician if symptoms persist for more than 7 days or worsen.

Section 50570-1

Do not use more than directed.

Section 53414-9

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Section 55106-9

Active ingredients	Purpose
Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated)	occasional sleeplessness
Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated)	anxiousness, worry
Kali Phosphoricum 3X HPUS	wakefulness, occasional sleeplessness, nervousness

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Directions

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Drug Facts

Other Information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive Ingredients

Acacia Gum, Lactose.

Questions Or Comments?

(800) 624-9659

Principal Display Panel 100 Tablet Bottle Carton

HOMEOPATHIC

NDC 54973-3206-1

SINCE 1903

Hyland's

Sleep*

NATURAL ACTIVE INGREDIENTS

GENTLE ON YOU

Relieves Occasional

Sleeplessness Due

to Nervousness

or Worry

100 QUICK-DISSOLVING TABLETS

* SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

NATURAL RELIEF

Structured Label Content

Uses

■ Temporarily relieves symptoms of occasional sleeplessness due to:

■ anxiousness ■ worry

■ wakefulness ■ nervousness

Section 34088-5 (34088-5)

Section 42229-5 (42229-5)

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children.

Section 50566-9 (50566-9)

Stop use and consult a physician if symptoms persist for more than 7 days or worsen.

Section 50570-1 (50570-1)

Do not use more than directed.

Section 53414-9 (53414-9)

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1 (55105-1)

Relieves Occasional Sleeplessness Due to Nervousness or Worry

Section 55106-9 (55106-9)

Active ingredients	Purpose
Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated)	occasional sleeplessness
Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated)	anxiousness, worry
Kali Phosphoricum 3X HPUS	wakefulness, occasional sleeplessness, nervousness

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Directions

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Drug Facts

Other Information (Other information)

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

 Temporarily relieves symptoms of occasional

sleeplessness due to:

 anxiousness  worry

 wakefulness  nervousness

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Dosage and Administration

Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

Principal Display Panel 100 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton)

HOMEOPATHIC

NDC 54973-3206-1

SINCE 1903

Hyland's

Sleep*

NATURAL ACTIVE INGREDIENTS

GENTLE ON YOU

Relieves Occasional

Sleeplessness Due

to Nervousness

or Worry

100 QUICK-DISSOLVING TABLETS

* SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

NATURAL RELIEF

Advanced Ingredient Data

[{"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYOSCYAMUS NIGER", "unii": "4WRK2153H3", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Temporarily relieves symptoms of occasional sleeplessness due to: ■ anxiousness ■ worry ■ wakefulness ■ nervousness", "34088-5": "In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.", "42229-5": "*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.", "50565-1": "Keep this and all medications out of the reach of children.", "50566-9": "Stop use and consult a physician if symptoms persist for more than 7 days or worsen.", "50570-1": "Do not use more than directed.", "53414-9": "As with any drug, ask a doctor before use if pregnant or breast-feeding.", "55105-1": "Relieves Occasional Sleeplessness Due to Nervousness or Worry", "55106-9": "Active ingredients Purpose Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated) occasional sleeplessness Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated) anxiousness, worry Kali Phosphoricum 3X HPUS wakefulness, occasional sleeplessness, nervousness "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.", "Directions": "Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.", "Other information": "■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.", "Inactive ingredients": "Acacia Gum, Lactose.", "Indications and Usage": " Temporarily relieves symptoms of occasional sleeplessness due to:  anxiousness  worry  wakefulness  nervousness", "Questions or comments?": "(800) 624-9659", "Dosage and Administration": "Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.", "PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton": "HOMEOPATHIC NDC 54973-3206-1 SINCE 1903 Hyland's Sleep* NATURAL ACTIVE INGREDIENTS GENTLE ON YOU Relieves Occasional Sleeplessness Due to Nervousness or Worry 100 QUICK-DISSOLVING TABLETS * SEE NOTE ON SIDE PANEL BELOW DRUG FACTS NATURAL RELIEF"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:51.899341 · Updated: 2026-03-14T23:15:51.329649