COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

Manufacturer: HOMEOLAB USA INC
Effective date: 2012-08-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:46:19

Label at a glance#

ProductCOUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

Active ingredientDROSERA ROTUNDIFOLIA, ARNICA MONTANA, BRYONIA ALBA ROOT, CETRARIA ISLANDICA SUBSP. ISLANDICA, ATROPA BELLADONNA, PROTORTONIA CACTI, TIN, MATRICARIA RECUTITA, ARABICA COFFEE BEAN

Label structure9 sections

Indications and uses

This homeopathic medicine helps relieve symptoms associated with nighttime cough and cold: - dry cough - cough with expectoration - chest congestion - fever - aches and pains

Dosage and administration

Do not use more than directed. Do not take with food. Take before bedtime. Repeat every 8 hours, as needed. Reduce intake with improvement or as directed by a healthcare professional. Age Dose 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. Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C

Coccus cacti (Cochineal) 3C

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

REFERENCES SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Mucus, cough and chills.

Restlessness, irritability and nocturnal awakenings.

Restlessness and sleeplessness.

USES

INDICATIONS & USAGE SECTION

This homeopathic medicine helps relieve symptoms associated with nighttime cough and cold:

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 5 days.

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.

Take before bedtime. Repeat every 8 hours, as needed. Reduce intake with improvement or as directed by a healthcare professional.


Age	Dose
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.

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.

CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60512-9021-4	2025-12-26	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9021-5	2025-12-26	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9021-9	2025-12-26	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9021-4	2020-01-31	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9021-5	2020-01-31	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9021-9	2020-01-31	C162847	48780-1	9d75b9d0-9856-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60512-9021	COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA) SYRUP [HOMEOLAB USA INC]	1	Legacy NDC	20120824_8dde330d-4257-4a46-9de8-95df7360aa66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	1
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	1
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	1
CETRARIA ISLANDICA SUBSP. ISLANDICA	ACTIVE INGREDIENT	BJ7YPN79A1	1
DROSERA ROTUNDIFOLIA	ACTIVE INGREDIENT	QR44N9XPJQ	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
PROTORTONIA CACTI	ACTIVE INGREDIENT	LZB7TFX1LT	1
TIN	ACTIVE INGREDIENT	387GMG9FH5	1
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	1
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	1
CETRARIA ISLANDICA SUBSP. ISLANDICA	ACTIVE MOIETY	BJ7YPN79A1	1
DROSERA ROTUNDIFOLIA	ACTIVE MOIETY	QR44N9XPJQ	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	1
PROTORTONIA CACTI	ACTIVE MOIETY	LZB7TFX1LT	1
TIN	ACTIVE MOIETY	387GMG9FH5	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF
DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA
DROSERA ROTUNDIFOLIA
ARNICA MONTANA
BRYONIA ALBA ROOT
CETRARIA ISLANDICA SUBSP. ISLANDICA
ATROPA BELLADONNA
PROTORTONIA CACTI
TIN
MATRICARIA RECUTITA
ARABICA COFFEE BEAN
WATER
SORBITOL
CARAMEL
SODIUM BENZOATE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60512-9021	60512-9021-9, 60512-9021-5, 60512-9021-4

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
DROSERA ROTUNDIFOLIA	QR44N9XPJQ	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
BRYONIA ALBA ROOT	T7J046YI2B	ACTIB
CETRARIA ISLANDICA SUBSP. ISLANDICA	BJ7YPN79A1	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
PROTORTONIA CACTI	LZB7TFX1LT	ACTIB
TIN	387GMG9FH5	ACTIB
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
ARABICA COFFEE BEAN	3SW678MX72	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
CARAMEL	T9D99G2B1R	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 · 195 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LOTION / TOPICAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		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	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 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
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	GRANULE, FOR SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 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
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 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
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		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
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 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	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 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	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 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
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 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
46e72a00-2ced-ca35-e063-6294a90a160d			8dde330d-4257-4a46-9de8-95df7360aa66	2025-12-26	Warnings	Exact identifier spl set id: 8dde330d-4257-4a46-9de8-95df7360aa66

Reported adverse events (FAERS/openFDA)#

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