Sleepcalm Pellets

Sleepcalm Pellets
SPL v3
SPL
SPL Set ID dda7a51d-7c2c-67f4-e053-2a95a90a8e72
Route
ORAL
Published
Effective Date 2024-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hyoscyamus Niger (3 [hp_C]) Datura Stramonium (6 [hp_X]) Passiflora Incarnata Top (3 [hp_X]) Nutmeg (4 [hp_C])
Inactive Ingredients
Lactose, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-04-27

Description

Active ingredients** (in each pellet) Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids) Nux moschata 4C HPUS (0.11 mg) Passiflora incarnata 3X HPUS (0.11 mg) Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


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

Directions

  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue at bedtime.
  • Children under 12 years of age: Ask a doctor.
Description

Active ingredients** (in each pellet) Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids) Nux moschata 4C HPUS (0.11 mg) Passiflora incarnata 3X HPUS (0.11 mg) Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine 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

Melatonin-Free

Sleep Relief*

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Calms Restless Mind*

No Known Drug Interactions

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8g, (0.13 oz)

Tube - Do not use if pellet dispenser seal is broken.

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

*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.

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 50566-9

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

lactose, sucrose

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

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

Hyoscyamus niger 3C HPUS (0.11 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.11 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.11 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.11 mg) ... Relieves sleeplessness with intermittent awakening

Section 55106-9

Active ingredients** (in each pellet)

Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids)

Nux moschata 4C HPUS (0.11 mg)

Passiflora incarnata 3X HPUS (0.11 mg)

Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine 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)

Directions

  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue at bedtime.
  • Children under 12 years of age: Ask a doctor.
Section 42229-5 (42229-5)

Melatonin-Free

Sleep Relief*

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Calms Restless Mind*

No Known Drug Interactions

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8g, (0.13 oz)

Tube - Do not use if pellet dispenser seal is broken.

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

*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.

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 50566-9 (50566-9)

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)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

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)

Hyoscyamus niger 3C HPUS (0.11 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.11 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.11 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.11 mg) ... Relieves sleeplessness with intermittent awakening

Section 55106-9 (55106-9)

Active ingredients** (in each pellet)

Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids)

Nux moschata 4C HPUS (0.11 mg)

Passiflora incarnata 3X HPUS (0.11 mg)

Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine 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


Raw Label Data

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