CALM N RESTFUL 4 KIDS

Manufacturer: Hyland's Inc.
Effective date: 2022-12-07
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 21:45:20

Label at a glance#

ProductCALM N RESTFUL 4 KIDS

Active ingredientACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SULFUR

Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

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

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

*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

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Do not use

OTC - DO NOT USE SECTION

More than directed.

Consult a physician if

OTC - ASK DOCTOR SECTION

Symptoms persist for more than 7 days or worsen.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of emergency

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION SECTION

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)

SPL UNCLASSIFIED SECTION

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses

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

Dosage and Administration

RECENT MAJOR CHANGES SECTION

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACONITUM NAPELLUS ROOT	ACTIVE INGREDIENT	KPD2N7348X	1
ARTEMISIA CINA PRE-FLOWERING TOP	ACTIVE INGREDIENT	28M1820ACT	1
CALCIUM PHOSPHATE	ACTIVE INGREDIENT	97Z1WI3NDX	1
CHAMOMILE	ACTIVE INGREDIENT	FGL3685T2X	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE INGREDIENT	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
ACONITUM NAPELLUS ROOT	ACTIVE MOIETY	KPD2N7348X	1
ARTEMISIA CINA PRE-FLOWERING TOP	ACTIVE MOIETY	28M1820ACT	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	1
CHAMOMILE	ACTIVE MOIETY	FGL3685T2X	1
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE MOIETY	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

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
ACACIA
LACTOSE
ACONITUM NAPELLUS ROOT
CALCIUM PHOSPHATE
CALCIUM CATION
CHAMOMILE
ARTEMISIA CINA PRE-FLOWERING TOP
LYCOPODIUM CLAVATUM SPORE
SODIUM CHLORIDE
CHLORIDE ION
PULSATILLA VULGARIS
SULFUR

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3161	54973-3161-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE	J2B2A4N98G	IACT
ACONITUM NAPELLUS ROOT	KPD2N7348X	ACTIB
CALCIUM PHOSPHATE	97Z1WI3NDX	ACTIB
CHAMOMILE	FGL3685T2X	ACTIB
ARTEMISIA CINA PRE-FLOWERING TOP	28M1820ACT	ACTIB
LYCOPODIUM CLAVATUM SPORE	C88X29Y479	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
SULFUR	70FD1KFU70	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / INTRAMUSCULAR	1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	GUM, CHEWING / BUCCAL		280 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SYRUP / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / BUCCAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f6f7ab8c-ffa7-6299-e053-6394a90ab0d8			8dae1ad1-14fa-4e4e-8c76-889ff1d0bee1	2023-03-15	Warnings	Exact identifier spl set id: 8dae1ad1-14fa-4e4e-8c76-889ff1d0bee1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.