CALM KIDS RELIEF

Manufacturer
HOMEOLAB USA INC
Effective date
2018-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:42:46

Label at a glance#

ProductCALM KIDS RELIEF
Active ingredientASAFETIDA, STRYCHNOS IGNATII SEED, VALERIAN, AVENA SATIVA FLOWERING TOP, SILVER NITRATE, LYCOSA TARANTULA, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT, DATURA STRAMONIUM, ANAMIRTA COCCULUS SEED
Label structure10 sections

Indications and uses

This homeopathic medicine helps relieve: - restlessness - nervousness - irritability - agitation - sleeplessness - lessens nightmares.

Dosage and administration

Do not use more than directed. Do not take with food. Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional. Children 6 years of age and older: 1 teaspoon Children 2 to 5 years of age: 1/2 teaspoon Children under 2 years of age: Ask a doctor.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS HPUS

OTC - ACTIVE INGREDIENT SECTION

Asafoetida (Asafetida) 8X

Ignatia amara (Ignatius bean) 8X

Valeriana officinalis (Valerian) 8X

Avena sativa (Oats) 8X

Argentum nitricum (Silver nitrate) 8X

Tarentula hispana (Tarantula) 8X

Hyoscyamus niger (Henbane) 8X

Paeonia officinalis (Peony) 8X

Stramonium (Thorn apple) 8X

Cocculus indicus (Indian berry) 8X

PURPOSE

OTC - PURPOSE SECTION

Restlessness and anxiety.

Nervousness.

Agitation.

Sleeplessness.

Nervousness.

Nightmares.

Anguish and fear.

Apprehension, anxiety and irritability.

Nightmares and nervousness.

Lack of concentration.

REFERENCES SECTION

This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

USES

INDICATIONS & USAGE SECTION

This homeopathic medicine helps relieve:

- restlessness

- nervousness

- irritability

- agitation

- sleeplessness

- lessens nightmares.

WARNINGS

WARNINGS SECTION


OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Do not use more than directed.

Do not take with food.

Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional.


Children 6 years of age and older: 1 teaspoon

Children 2 to 5 years of age: 1/2 teaspoon

Children under 2 years of age: Ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130778159090646GTIN-13: 0778159090646
EAN-13: 0778159090646
GTIN-12: 778159090646
UPC-A: 778159090646
GTIN storage (14 digits): 00778159090646
Calm carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-9064-52025-12-28C16284748780-19d75b9d1-1bba-f424-e053-dadaa90a57ceDRUGS FACTS
60512-9064-52020-01-31C16284748780-19d75b9d1-1bba-f424-e053-dadaa90a57ceDRUGS FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9064CALM KIDS RELIEF (ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, TARENTULA HISPANA, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS) SYRUP [HOMEOLAB USA INC]3Legacy NDC20181214_8b68fd02-6d7c-4945-9ead-f2cee9dcd684.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28U1
ASAFETIDAACTIVE INGREDIENTW9FZA51AS11
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
DATURA STRAMONIUMACTIVE INGREDIENTG6W4F0V8Z31
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H31
LYCOSA TARANTULAACTIVE INGREDIENT86M454L2TT1
PAEONIA OFFICINALIS ROOTACTIVE INGREDIENT8R564U2E1P1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZE1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28U1
ASAFETIDAACTIVE MOIETYW9FZA51AS11
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
DATURA STRAMONIUMACTIVE MOIETYG6W4F0V8Z31
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H31
LYCOSA TARANTULAACTIVE MOIETY86M454L2TT1
PAEONIA OFFICINALIS ROOTACTIVE MOIETY8R564U2E1P1
SILVER CATIONACTIVE MOIETY57N7B0K90A1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
VALERIANACTIVE MOIETYJWF5YAW3QW1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-906460512-9064-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 4 · 186 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SUBCUTANEOUS28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
470edd9c-6c10-6c12-e063-6294a90aaff68b68fd02-6d7c-4945-9ead-f2cee9dcd6842025-12-28WarningsExact identifier
spl set id: 8b68fd02-6d7c-4945-9ead-f2cee9dcd684

Reported adverse events (FAERS/openFDA)#

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