CALM N RESTFUL 4 KIDS- aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet

CALM N RESTFUL 4 KIDS by

Drug Labeling and Warnings

CALM N RESTFUL 4 KIDS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Aconitum Napellus 6X HPUS: physical & mental restlessness
• Calcarea Phosphorica 12X HPUS: peevishness
• Chamomilla 6X HPUS: irritability, restlessness, occasional sleeplessness
• Cina 6X HPUS: irritability of temper
• Lycopodium 6X HPUS: lack of focus, extreme sensitivity
• Natrum Muriaticum 6X HPUS: irritability, crying, oversensitivity
• Pulsatilla 6X HPUS: occasional sleeplessness from travel
• Sulphur 6X HPUS: irritability, peevishness

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

PURPOSE

Temporarily relieves the symptoms of occasional sleeplessness, mental and physical restlessness, irritability, and occasional sleeplessness due to travel and lack of focus in children.

Uses

Temporarily relieves the symptoms of occasional sleeplessness, mental and physical restlessness, irritability, and occasional sleeplessness due to travel and lack of focus in children.

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Consult a physician if:

• Symptoms persist for more than 7 days or worsen
• Child is taking any prescription medicines

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or a poison control center immediately.

Do not use if imprinted tamper band is broken or missing.

In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Children 2 years to under 6 years: dissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
• Children 6 years to under 12 years: dissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
• Adults and children 12 years and over: dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required

Inactive ingredients

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

Natural
Relief

NDC: 54973-3161-1
HOMEOPATHIC

Ages
2-12

SINCE 1903
Hyland's®

4 Kids

Calm 'n
Restful*

Occasional Sleeplessness

Mental & Physical Restlessness

Irritability

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

SAFE &
EFFECTIVE

INGREDIENTS AND APPEARANCE

CALM N RESTFUL 4 KIDS 
aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3161
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X)	ACONITUM NAPELLUS ROOT	6 [hp_X]
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	12 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	6 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3161-1	1 in 1 CARTON	06/10/2013
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/10/2013

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3161)