SLEEPCALM- hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet

SleepCalm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Hyoscyamus niger 3C HPUS (0.6 mg) (contains less than 10- 9 mg alkaloids)
Nux moschata 4C HPUS (0.6 mg)
Passiflora incarnata 3X HPUS (0.6 mg)
Stramonium 6X HPUS (0.6 mg) (contains less than 10- 8 mg alkaloids)

PURPOSE

Hyoscyamus niger 3C HPUS (0.6 mg) (contains less than 10-9 mg alkaloids) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.6 mg) ... Relieves restless sleep
Passiflora incarnata 3X HPUS (0.6 mg) ... Relieves sleeplessness associated with worries and exhaustion
Stramonium 6X HPUS (0.6 mg) (contains less than 10-8 mg alkaloids) ... Relieves sleeplessness with intermittent awakening

INDICATIONS & USAGE

Temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening, helps reduce difficutly falling asleep due to: nervousness, worries

WARNINGS

ASK DOCTOR

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 breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older: Allow 2 tablets to dissolve under the tongue at bedtime.

Children under 12 of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

Do not use if glued carton end flaps are open or if the blister seal is broken.

store below 86 oF (30 oC)

Contains 60 meltaway tablets

*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.

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

No known drug interactions

No artificial colors, flavors or sweeteners

Plant based actives

No daytime grogginess

INACTIVE INGREDIENT

Croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

BoironUSA.com

Info@boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLEEPCALM 
hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9310
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	4 [hp_C]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	3 [hp_X]
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]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9310-04	1 in 1 PACKAGE	04/01/2020
1		60 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2020

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9310)