SleepCalm Kids

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-08-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:27:45

Label at a glance#

ProductSleepCalm Kids
Active ingredientDATURA STRAMONIUM, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

SPL UNCLASSIFIED SECTION

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.

INACTIVE INGREDIENT SECTION

alcohol, purified water,

OTC - QUESTIONS SECTION

BoironUSA.com Info@boiron.com

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

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9309-092023-02-14C16284748780-1f386c64a-2b7c-0266-e053-dadaa90a7c1aSleepCalm Kids
0220-9309-092023-01-30C16284748780-1f386c64a-2b7c-0266-e053-dadaa90a7c1aSleepCalm Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9309-07SleepCalm Kids5 in 1 POUCHLIQUID56
0220-9309-09SleepCalm Kids15 in 1 POUCHLIQUID156
0220-9309-09SleepCalm Kids1 in 1 BOXLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9309SLEEPCALM KIDS (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) LIQUID [BOIRON]6Current NDC, Legacy NDC, 3 package rows20240814_aef7b774-355a-3fb8-e053-2a95a90a268c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93090220-9309-09, 0220-9309-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SleepCalm KidsMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironaef7b774-355a-3fb8-e053-2a95a90a268c2024-08-09Exact identifier
ndc (package): 0220-9309-09
ndc (package): 0220-9309-07
ndc (product): 0220-9309
ndc11 (package): 00220930909
ndc11 (package): 00220930907
spl id: 1f452ffb-58f3-8ade-e063-6394a90ad0c8
spl set id: aef7b774-355a-3fb8-e053-2a95a90a268c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.