WITH CALMING EFFECT KIDS RELIEF

Manufacturer: HOMEOLAB USA INC
Effective date: 2014-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:48

Label at a glance#

ProductWITH CALMING EFFECT KIDS RELIEF

Active ingredientASAFETIDA, STRYCHNOS IGNATII SEED, VALERIAN, AVENA SATIVA FLOWERING TOP, SILVER NITRATE, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT, DATURA STRAMONIUM, ANAMIRTA COCCULUS SEED

Label structure10 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of: • restlessness • nervousness • irritability • agitation • sleeplessness • lessens nightmares

Dosage and administration

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product. Children 6 months to 2 years old: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

Storage and handling

Store at room temperature. Do not use if seal is broken or missing.

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

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

Anguish and fear

Apprehension, anxiety and irritability

Nightmares and nervousness

Lack of concentration

REFERENCES SECTION

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Uses

INDICATIONS & USAGE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

• restlessness

• nervousness

• irritability

• agitation

• sleeplessness

• lessens nightmares

Warnings

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Do not use if seal is broken or missing.

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

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60512-9164-5	2025-12-28	C162847	48780-1	9d75b9cf-f75b-f424-e053-dadaa90a57ce	DRUGS FACTS
60512-9164-5	2020-01-31	C162847	48780-1	9d75b9cf-f75b-f424-e053-dadaa90a57ce	DRUGS FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60512-9164	WITH CALMING EFFECT KIDS RELIEF (ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS) SYRUP [HOMEOLAB USA INC]	2	Legacy NDC	20140402_b9b2ac55-c7f6-4d35-85f3-80d3494bc8af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ANAMIRTA COCCULUS SEED	ACTIVE INGREDIENT	810258W28U	2
ASAFETIDA	ACTIVE INGREDIENT	W9FZA51AS1	2
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	2
DATURA STRAMONIUM	ACTIVE INGREDIENT	G6W4F0V8Z3	2
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	2
PAEONIA OFFICINALIS ROOT	ACTIVE INGREDIENT	8R564U2E1P	2
SILVER NITRATE	ACTIVE INGREDIENT	95IT3W8JZE	2
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	2
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	2
ANAMIRTA COCCULUS SEED	ACTIVE MOIETY	810258W28U	2
ASAFETIDA	ACTIVE MOIETY	W9FZA51AS1	2
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	2
DATURA STRAMONIUM	ACTIVE MOIETY	G6W4F0V8Z3	2
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	2
PAEONIA OFFICINALIS ROOT	ACTIVE MOIETY	8R564U2E1P	2
SILVER CATION	ACTIVE MOIETY	57N7B0K90A	2
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	2
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

WITH CALMING EFFECT KIDS RELIEF
ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS
ASAFETIDA
STRYCHNOS IGNATII SEED
VALERIAN
AVENA SATIVA FLOWERING TOP
SILVER NITRATE
SILVER CATION
HYOSCYAMUS NIGER
PAEONIA OFFICINALIS ROOT
DATURA STRAMONIUM
ANAMIRTA COCCULUS SEED
WATER
SORBITOL
SODIUM BENZOATE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60512-9164	60512-9164-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASAFETIDA	W9FZA51AS1	ACTIB
STRYCHNOS IGNATII SEED	1NM3M2487K	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
SILVER NITRATE	95IT3W8JZE	ACTIB
HYOSCYAMUS NIGER	4WRK2153H3	ACTIB
PAEONIA OFFICINALIS ROOT	8R564U2E1P	ACTIB
DATURA STRAMONIUM	G6W4F0V8Z3	ACTIB
ANAMIRTA COCCULUS SEED	810258W28U	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	AEROSOL, FOAM / TOPICAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	ELIXIR / ORAL	100 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 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
470dc545-b1b5-e1b1-e063-6394a90a4f60			b9b2ac55-c7f6-4d35-85f3-80d3494bc8af	2025-12-28	Warnings	Exact identifier spl set id: b9b2ac55-c7f6-4d35-85f3-80d3494bc8af

Reported adverse events (FAERS/openFDA)#

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