Label: SLEEPCALM- matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium pellet
- NDC Code(s): 0220-9308-41, 0220-9308-42
- 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 September 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients** (in each pellet)
Chamomilla 9C HPUS (0.07 mg)
Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)
Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)
Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)
Passiflora incarnata 3C HPUS (0.07 mg)
Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 mg atropine alkaloids)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
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
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Melatonin-Free
Kids Sleep Aid*
Restores a Natural Sleep Pattern
Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)
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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLEEPCALM
matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9308 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 9 [hp_C] POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 9 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 9 [hp_C] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_C] MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 9 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 9 [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:0220-9308-42 2 in 1 BOX 05/02/2022 1 NDC:0220-9308-41 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 05/02/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9308)
