SLEEPCALM- matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, 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)

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

Purpose*

Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening

INDICATIONS & USAGE

Uses*

• temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:

• restless sleep
• intermittent awakening
• irritability
• nightmares
• night terrors

• reduces time to fall asleep if your child has difficulty falling asleep

WARNINGS

DO NOT USE

Do not use if your child has a known allergy to any ingredients in this product.

STOP USE

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.

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

• Children 3 years of age or older: Dissolve 5 pellets under the tongue at bedtime, and again during the night if needed, for up to a total of 2 doses per night.
• Children under 3 years of age: Ask a doctor.

INACTIVE INGREDIENT

lactose, sucrose

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*

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

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLEEPCALM 
matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium pellet

Product 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)