SLEEPCALM- hyoscyamus niger, nutmeg, passiflora incarnata flowering top, datura stramonium pellet

SleepCalm by

Drug Labeling and Warnings

SleepCalm by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients** (in each pellet)

Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine 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 atropine 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

Uses*

• temporarily relieves:
• occasional sleeplessness
• restless sleep
• intermittent awakening

• helps reduce difficulty falling asleep due to:
• nervousness
• worries

WARNINGS

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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

QUESTIONS

BoironUSA.com

Info@Boiron.Com

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA 19073

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

Calms Restless Mind*

No Known Drug Interactions

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 pellet

Product 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)