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
Hyland's Inc.

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.

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Kids Calm & Restful

Temporarily relieves symptoms of irritability or restlessness in children, including: occasional sleeplessness, physical or mental restlessness, peevishness, crying, oversensitivity, lack of focus

Drug Facts

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.

Uses

■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ physical or mental restlessness ■ peevishness ■ crying oversensitivity ■ lack of focus

Warnings

If pregnant or breastfeeding

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

Do not use

More than directed.

Consult a physician if

Symptoms persist for more than 7 days or worsen.

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

In case of emergency

or accidental overdose, 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 up to 8 doses, then every 4 hours until relieved.
Children 6 years to under 12 years	Dissolve 3 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved.
Adults and children 12 years and over	Dissolve 4 tablets under tongue every 15 minutes up to 8 doses, then every 4 hours until relieved.

Drug Facts (continued)

Other Information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
■ The inner packaged bottle is child-resistant.

Inactive ingredients

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-3161-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

Calm &

Restful*

Relieves irritability, restlessness
and occasional sleeplessness

NATURAL

RELIEF

NO ARTIFICIAL FLAVORS,

NO DYES or PARABENS

125

QUICK-DISSOLVING

TABLETS

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/10/2013	03/15/2023

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3161) , pack(54973-3161) , label(54973-3161)

Revised: 3/2023

Document Id: f6f7ab8c-ffa7-6299-e053-6394a90ab0d8

Set id: 8dae1ad1-14fa-4e4e-8c76-889ff1d0bee1

Version: 8

Effective Time: 20230315

Hyland's Inc.