FDA Label for Sleepcalm Kids
View Indications, Usage & Precautions
Sleepcalm Kids Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Chamomilla 9C HPUS (0.17 mL)** (in each mL vial)
Gelsemium sempervirens 9C HPUS (0.17 mL)** (in each mL vial) (contains less than 10 -17 mg gelsemine alkaloids)
Hyoscyamus niger 9C HPUS (0.17mL)** (in each mL vial) (contains less than 10 -18 mg atropine alkaloids)
Kali bromatum 9C HPUS (0.17mL)** (in each mL vial) (contains less than 10 -15 mg bromide)
Passiflora incarnata 3C HPUS (0.17 mL)** (in each mL vial)
Starmonium 9C HPUS (0.17 mL)** (in each mL vial) (contains less than 10 -18 mg atropine alkaloids)
Otc - 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
*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
Do not use if your child has a known allergy to any ingredient in this product.
Otc - Stop Use
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
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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.
Other
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 at a temperature that does not exceed
77oF (25oC)
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
0.34 fl oz (1 mL) each
15 pre-measured liquid doses
99.99% alcohol-free
Fall Asleep, Stay Asleep
No Daytime Grogginess
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
*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
purified water, alcohol
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
* Please review the disclaimer below.