Sleepcalm Kids

Sleepcalm Kids
SPL v6
SPL
SPL Set ID aef7b774-355a-3fb8-e053-2a95a90a268c
Route
ORAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Datura Stramonium (9 [hp_C]) Bromide Ion (3 [hp_C]) Passiflora Incarnata Flowering Top Matricaria Chamomilla Whole Gelsemium Sempervirens Root Hyoscyamus Niger
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-09-10

Description

Active ingredients** (in each 1 mL vial) Chamomilla 9C HPUS (0.17 mL) Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids) Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids) Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide) Passiflora incarnata 3C HPUS (0.17 mL) Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 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 the time to fall asleep if your child has difficulty falling asleep
Dosage and Administration

Children 3 years of age and older: Give 1 dose at bedtime, and again during the night if needed for up to a total of 2 doses per night.

Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. Squeeze entire contents into mouth.

Description

Active ingredients** (in each 1 mL vial) Chamomilla 9C HPUS (0.17 mL) Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids) Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids) Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide) Passiflora incarnata 3C HPUS (0.17 mL) Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 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 inner foil pouch and vials are not intact

do not refrigerate or freeze

after opening the foil pouch: store unused vials in the foil pouch for no longer than 3 months

after opening the vial: the product must be used immediately

after administering: discard vial

do not reuse

contains 0.0015% alcohol

Calms Restless Sleep*

Kids Sleep Aid*

Melatonin Free

15 pre-measured liquid doses

5 pre-measured liquid doses

0.34 fl oz (1 mL) each

99.99% alcohol-free

Fall Asleep, Stay Asleep

*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 accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop and 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 ingredient in this product.

Section 51727-6

alcohol, purified water,

Section 51945-4

Section 53413-1

BoironUSA.com [email protected]

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

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 55105-1

Purpose*

Chamomilla 9C HPUS ... Relieves restlessness, irritability, and crying during sleep

Gelsemium sempervirens 9C HPUS ... Relieves sleeplessness due to apprehension

Hyoscyamus niger 9C HPUS ... Relieves irritability and restless sleep associated with nervousness

Kali bromatum 9C HPUS ... Relieves irritability and restless sleep with night terrors

Passiflora incarnata 3C HPUS ... Relieves occasional restless sleep

Starmonium 9C HPUS ... Relieves restless sleep with intermittent awakening, nightmares and night terrors

Section 55106-9

Active ingredients** (in each 1 mL vial)

Chamomilla 9C HPUS (0.17 mL)

Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids)

Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids)

Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide)

Passiflora incarnata 3C HPUS (0.17 mL)

Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 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 the time to fall asleep if your child has difficulty falling asleep
Dosage and Administration (34068-7)

Children 3 years of age and older: Give 1 dose at bedtime, and again during the night if needed for up to a total of 2 doses per night.

Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. Squeeze entire contents into mouth.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact

do not refrigerate or freeze

after opening the foil pouch: store unused vials in the foil pouch for no longer than 3 months

after opening the vial: the product must be used immediately

after administering: discard vial

do not reuse

contains 0.0015% alcohol

Calms Restless Sleep*

Kids Sleep Aid*

Melatonin Free

15 pre-measured liquid doses

5 pre-measured liquid doses

0.34 fl oz (1 mL) each

99.99% alcohol-free

Fall Asleep, Stay Asleep

*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 accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop and 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 ingredient in this product.

Section 51727-6 (51727-6)

alcohol, purified water,

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com [email protected]

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

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 55105-1 (55105-1)

Purpose*

Chamomilla 9C HPUS ... Relieves restlessness, irritability, and crying during sleep

Gelsemium sempervirens 9C HPUS ... Relieves sleeplessness due to apprehension

Hyoscyamus niger 9C HPUS ... Relieves irritability and restless sleep associated with nervousness

Kali bromatum 9C HPUS ... Relieves irritability and restless sleep with night terrors

Passiflora incarnata 3C HPUS ... Relieves occasional restless sleep

Starmonium 9C HPUS ... Relieves restless sleep with intermittent awakening, nightmares and night terrors

Section 55106-9 (55106-9)

Active ingredients** (in each 1 mL vial)

Chamomilla 9C HPUS (0.17 mL)

Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids)

Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids)

Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide)

Passiflora incarnata 3C HPUS (0.17 mL)

Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 mg atropine alkaloids)

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


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