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

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

Medication Information

Active Ingredient

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.

Uses

■ Temporarily relieves symptoms of occasional sleeplessness due to:

■ anxiousness ■ worry

■ wakefulness ■ nervousness

Indications and Usage

 Temporarily relieves symptoms of occasional

sleeplessness due to:

 anxiousness  worry

 wakefulness  nervousness

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.

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.

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.

Description

Relieves Occasional Sleeplessness Due to Nervousness or Worry

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

Drug Facts

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

Active Ingredient (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.

Uses

■ Temporarily relieves symptoms of occasional sleeplessness due to:

■ anxiousness ■ worry

■ wakefulness ■ nervousness

Indications and Usage

 Temporarily relieves symptoms of occasional

sleeplessness due to:

 anxiousness  worry

 wakefulness  nervousness

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.

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.

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.

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

Drug Facts

Questions Or Comments? (Questions or comments?)

(800) 624-9659

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