The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Sleepcalm (NDC 0220-9311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
Uses*
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.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
lactose, sucrose
BoironUSA.com
1-800-264-7661
Made in France
Distributed by
Boiron, Inc.
Newtown Square, PA 19073
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.
