COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

Manufacturer: HOMEOLAB USA INC
Effective date: 2014-04-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:28

Label at a glance#

ProductCOUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

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

Label structure9 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with nighttime cough and cold*: • dry cough • cough with expectoration • chest congestion • fever • aches and pains

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 8 hours or 3 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 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

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C - Calculated as 0.0000003% alkaloids

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

Purpose

OTC - PURPOSE SECTION

Dry cough

Aches and pains, chest congestion

Painful cough

Cough with expectoration

Cold and fever

Cough with expectoration

Painful cough

Mucus, cough and chills

Restlessness, irritability and nocturnal awakenings

Restlessness and sleeplessness

REFERENCES SECTION

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic 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 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 if • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a medical professional or 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 8 hours or 3 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 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, 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
60512-9081-4	2025-12-26	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9081-5	2025-12-26	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9081-9	2025-12-26	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9081-4	2020-01-31	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9081-5	2020-01-31	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS
60512-9081-9	2020-01-31	C162847	48780-1	9d75b9d1-001b-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60512-9081	COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA) SYRUP [HOMEOLAB USA INC]	2	Legacy NDC	20140429_beff0858-ed6c-49e2-b8b2-76d2b08b288e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	2
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	2
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	2
CETRARIA ISLANDICA SUBSP. ISLANDICA	ACTIVE INGREDIENT	BJ7YPN79A1	2
CORALLIUM RUBRUM EXOSKELETON	ACTIVE INGREDIENT	2CA71K0DLE	2
DROSERA ROTUNDIFOLIA FLOWERING TOP	ACTIVE INGREDIENT	75O014T1HG	2
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	2
PROTORTONIA CACTI	ACTIVE INGREDIENT	LZB7TFX1LT	2
TIN	ACTIVE INGREDIENT	387GMG9FH5	2
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	2
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	2
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	2
CETRARIA ISLANDICA SUBSP. ISLANDICA	ACTIVE MOIETY	BJ7YPN79A1	2
CORALLIUM RUBRUM EXOSKELETON	ACTIVE MOIETY	2CA71K0DLE	2
DROSERA ROTUNDIFOLIA FLOWERING TOP	ACTIVE MOIETY	75O014T1HG	2
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	2
PROTORTONIA CACTI	ACTIVE MOIETY	LZB7TFX1LT	2
TIN	ACTIVE MOIETY	387GMG9FH5	2
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	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 · 18 matching rows.

COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF
DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA
DROSERA ROTUNDIFOLIA FLOWERING TOP
ARNICA MONTANA
BRYONIA ALBA ROOT
CETRARIA ISLANDICA SUBSP. ISLANDICA
ATROPA BELLADONNA
PROTORTONIA CACTI
CORALLIUM RUBRUM EXOSKELETON
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
60512-9081	60512-9081-5, 60512-9081-4, 60512-9081-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DROSERA ROTUNDIFOLIA FLOWERING TOP	75O014T1HG	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
BRYONIA ALBA ROOT	T7J046YI2B	ACTIB
CETRARIA ISLANDICA SUBSP. ISLANDICA	BJ7YPN79A1	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
PROTORTONIA CACTI	LZB7TFX1LT	ACTIB
CORALLIUM RUBRUM EXOSKELETON	2CA71K0DLE	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
CARAMEL	CARAMEL	T9D99G2B1R	GRANULE, FOR SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 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
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 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
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 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	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 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	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 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
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	CREAM / TOPICAL	0.26 %w/w		Exact identifier — unii candidate 9 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	INJECTION, SOLUTION / SUBCUTANEOUS		26 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	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
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 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	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 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
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 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
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		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	SPRAY, METERED / NASAL		2 mg	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
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 / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 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
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
46e5c95e-4061-3283-e063-6394a90ae47b			beff0858-ed6c-49e2-b8b2-76d2b08b288e	2025-12-26	Warnings	Exact identifier spl set id: beff0858-ed6c-49e2-b8b2-76d2b08b288e

Reported adverse events (FAERS/openFDA)#

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