Label: SLEEPCALM- hyoscyamus niger, nutmeg, passiflora incarnata flowering top, datura stramonium pellet
- NDC Code(s): 0220-9311-41, 0220-9311-42
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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.
-
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
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
-
SPL UNCLASSIFIED SECTION
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. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SLEEPCALM
hyoscyamus niger, nutmeg, passiflora incarnata flowering top, datura stramonium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 3 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 6 [hp_X] PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP 3 [hp_X] NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 4 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9311-42 2 in 1 BOX 04/27/2022 1 NDC:0220-9311-41 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/27/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9311)
