Sleepcalm Kids Pellet

Sleepcalm Kids Pellet
SPL v3
SPL
SPL Set ID de0b458d-5f0a-78f4-e053-2995a90afe4b
Route
ORAL
Published
Effective Date 2025-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Gelsemium Sempervirens Root (9 [hp_C]) Bromide Ion (3 [hp_C]) Hyoscyamus Niger Passiflora Incarnata Flowering Top Matricaria Chamomilla Whole Datura Stramonium
Inactive Ingredients
Lactose, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-05-02
Description

Active ingredients** (in each pellet) Chamomilla 9C HPUS (0.07 mg) Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine) Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids) Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide) Passiflora incarnata 3C HPUS (0.07 mg) Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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 symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:

  • restless sleep
  • intermittent awakening
  • irritability
  • nightmares
  • night terrors

  • reduces time to fall asleep if your child has difficulty falling asleep
Dosage and Administration

Directions

  • Children 3 years of age or older: Dissolve 5 pellets under the tongue at bedtime, and again during the night if needed, for up to a total of 2 doses per night.
  • Children under 3 years of age: Ask a doctor.
Description

Active ingredients** (in each pellet) Chamomilla 9C HPUS (0.07 mg) Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine) Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids) Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide) Passiflora incarnata 3C HPUS (0.07 mg) Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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

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

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Melatonin-Free

Kids Sleep Aid*

Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)

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 symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.

Section 50570-1

Do not use if your child has a known allergy to any ingredients in this product.

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 55105-1

Purpose*

Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening

Section 55106-9

Active ingredients** (in each pellet)

Chamomilla 9C HPUS (0.07 mg)

Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)

Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)

Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)

Passiflora incarnata 3C HPUS (0.07 mg)

Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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 symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:

  • restless sleep
  • intermittent awakening
  • irritability
  • nightmares
  • night terrors

  • reduces time to fall asleep if your child has difficulty falling asleep
Dosage and Administration (34068-7)

Directions

  • Children 3 years of age or older: Dissolve 5 pellets under the tongue at bedtime, and again during the night if needed, for up to a total of 2 doses per night.
  • Children under 3 years of age: Ask a doctor.
Section 42229-5 (42229-5)

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

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Melatonin-Free

Kids Sleep Aid*

Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)

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 symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.

Section 50570-1 (50570-1)

Do not use if your child has a known allergy to any ingredients in this product.

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 55105-1 (55105-1)

Purpose*

Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening

Section 55106-9 (55106-9)

Active ingredients** (in each pellet)

Chamomilla 9C HPUS (0.07 mg)

Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)

Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)

Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)

Passiflora incarnata 3C HPUS (0.07 mg)

Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:59.092737 · Updated: 2026-03-14T23:17:17.958365