FDA Label for Sleepcalm
View Indications, Usage & Precautions
Sleepcalm 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
Active ingredients** (in each pellet)
Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -11 mg 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 alkaloids)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
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
Indications & Usage
Uses*
- temporarily relieves
- occasional sleeplessness
- restless sleep
- intermittent awakening
- helps reduce difficulty falling asleep due to:
- nervousness
- worries
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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.
Inactive Ingredient
lactose, sucrose
Otc - Questions
BoironUSA.com
1-800-264-7661
Made in France
Distributed by
Boiron, Inc.
Newtown Square, PA 19073
Other
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
Plant-Powered Relief
Meltaway Pellets
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.
* Please review the disclaimer below.