Sleepcalm

Drug Facts

Composition & Product

Active Ingredients

Hyoscyamus Niger (3 [hp_C]) Passiflora Incarnata Top (3 [hp_X]) Datura Stramonium (6 [hp_X]) Nutmeg (4 [hp_C])

Inactive Ingredients

Croscarmellose Sodium Lactose, Unspecified Form Magnesium Stearate

Identifiers & Packaging

Pill Appearance

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

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2020-04-01

Medication Information

Indications and Usage

Uses*

temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening

helps reduce difficulty falling asleep due to: nervousness, worries

Dosage and Administration

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime.

Children under 12 of age: Ask a doctor.

Description

Active Ingredients** (in each tablet) Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids) Nux moschata 4C HPUS (0.63 mg) Passiflora incarnata 3X HPUS (0.63 mg) Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 ^oF (30 ^oC)

Contains 20 meltaway tablets

Contains 60 meltaway tablets

Contains 100 meltaway tablets

Contains 120 meltaway tablets

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

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Calms Restless Mind*

No Known Drug Interactions

Non-habit forming

No artificial sweetners or flavors

Gluten-free

Melatonin-Free

Sleep Relief*

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose*

Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening

Section 55106-9

Active Ingredients** (in each tablet)

Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 ^-9mg alkaloids)

Nux moschata 4C HPUS (0.63 mg)

Passiflora incarnata 3X HPUS (0.63 mg)

Stramonium 6X HPUS (0.63 mg) (contains less than 10- ⁸ mg alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening

helps reduce difficulty falling asleep due to: nervousness, worries

Dosage and Administration (34068-7)

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime.

Children under 12 of age: Ask a doctor.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 ^oF (30 ^oC)

Contains 20 meltaway tablets

Contains 60 meltaway tablets

Contains 100 meltaway tablets

Contains 120 meltaway tablets

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

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Calms Restless Mind*

No Known Drug Interactions

Non-habit forming

No artificial sweetners or flavors

Gluten-free

Melatonin-Free

Sleep Relief*

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening

Section 55106-9 (55106-9)

Active Ingredients** (in each tablet)

Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 ^-9mg alkaloids)

Nux moschata 4C HPUS (0.63 mg)

Passiflora incarnata 3X HPUS (0.63 mg)

Stramonium 6X HPUS (0.63 mg) (contains less than 10- ⁸ mg alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYOSCYAMUS NIGER", "unii": "4WRK2153H3", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "PASSIFLORA INCARNATA TOP", "unii": "CLF5YFS11O", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "DATURA STRAMONIUM", "unii": "G6W4F0V8Z3", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NUTMEG", "unii": "AEE24M3MQ9", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses* temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening helps reduce difficulty falling asleep due to: nervousness, worries", "34068-7": "Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime. Children under 12 of age: Ask a doctor.", "42229-5": "do not use if glued carton end flaps are open or if the blister seal is broken store below 86 o F (30 o C) Contains 20 meltaway tablets Contains 60 meltaway tablets Contains 100 meltaway tablets Contains 120 meltaway tablets *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details. Calms Restless Mind* No Known Drug Interactions Non-habit forming No artificial sweetners or flavors Gluten-free Melatonin-Free Sleep Relief*", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "50569-3": "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.", "51727-6": "croscarmellose sodium, lactose, magnesium stearate", "53413-1": "BoironUSA.com Info@boiron.com 1-800-BOIRON-1 (1-800-264-7661) Made in France Distributed by Boiron, Inc. Newtown Square, PA 19073", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose* Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening", "55106-9": "Active Ingredients** (in each tablet) Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids) Nux moschata 4C HPUS (0.63 mg) Passiflora incarnata 3X HPUS (0.63 mg) Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information