Kids Cough and Fever Relief

Manufacturer: Similasan Corporation
Effective date: 2013-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:06:33

Label at a glance#

ProductKids Cough and Fever Relief

Active ingredientATROPA BELLADONNA, DROSERA ROTUNDIFOLIA, PRUNUS LAUROCERASUS LEAF, RUMEX CRISPUS ROOT, POLYGALA SENEGA ROOT, VERBASCUM THAPSUS

Label structure19 sections

Indications and uses

Temporarily relieves symptoms of dry/tickling cough, fever, and nasal congestion due to throat and bronchial irritation occurring with a cold.

Dosage and administration

For children age 2 and over: AGE DOSE FREQUENCY 2-12 2.5 ml 3 to 6 times daily (every 4 hours) 12+ 5 ml 3 to 6 times daily (every 4 hours) Replace cap tightly after every use Or use as directed by a licensed health care professional.

Contacts and useful links#

PhoneLabel contact1-800-240-9780

Websitewww.similasanusa.com

www.SimilasanUSA.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X
* containing 0.0000000016% alkaloids conculated as hyoscyamine

Purpose

OTC - PURPOSE SECTION

fever

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Drosera 3X

Purpose

OTC - PURPOSE SECTION

nighttime spasmodic, hacking, tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Laurocerasus 4X

Purpose

OTC - PURPOSE SECTION

fever, hacking, dry cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Rumex crispus 4X

Purpose

OTC - PURPOSE SECTION

hoarse throat, nasal congestion, dry cough worse with cold air

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Senega officinalis 6X

Purpose

OTC - PURPOSE SECTION

nasal congestion, dry/tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Verbascum thapsus 6X

Purpose

OTC - PURPOSE SECTION

hoarse throat, spasmodic cough at night

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of dry/tickling cough, fever, and nasal congestion due to throat and bronchial irritation occurring with a cold.

Warnings

WARNINGS SECTION

Initial exacerbation of symptoms may occur.
Do not exceed recommended dosage.
Not intended for children under 2.
A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

if symptoms worsen or persist for more than 72 hours

Directions:

DOSAGE & ADMINISTRATION SECTION

For children age 2 and over:

AGE	DOSE	FREQUENCY
2-12	2.5 ml	3 to 6 times daily (every 4 hours)
12+	5 ml	3 to 6 times daily (every 4 hours)

Replace cap tightly after every use

Or use as directed by a licensed health care professional.

dosing scoop

Other Information:

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified water, Sorbitol, Sodium chloride, Potassium sorbate, Citric acid

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780
or getinfo@similasanusa.com
www.SimilasanUSA.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-259-25
Similasan
Kids Cough & Fever Relief
Cough & Fever Syrup
118 ml / 4fl oz

NDC 59262-259-25 Similasan Kids Cough & Fever Relief Cough & Fever Syrup 118 ml / 4fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59262-259-25	2020-01-31	C162847	48780-1	9d75b9d0-b356-f424-e053-dadaa90a57ce	Kids Cough and Fever Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59262-259-25	Kids Cough and Fever Relief	118 mL in 1 BOTTLE, GLASS	SYRUP	118		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59262-259	KIDS COUGH AND FEVER RELIEF (ATROPA BELLADONNA AND DROSERA ROTUNDIFOLIA AND PRUNUS LAUROCERASUS LEAF AND RUMEX CRISPUS ROOT AND POLYGALA SENEGA ROOT AND VERBASCUM THAPSUS) SYRUP [SIMILASAN CORPORATION]	4	Legacy NDC, 1 package rows	20150309_b66edb36-f438-4eaf-b7e1-7e291fccd0ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59262-259-25	ML - Milliliter	59262-259	c81eb472-ac84-4ba1-a455-805da620251b	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	4
DROSERA ROTUNDIFOLIA	ACTIVE INGREDIENT	QR44N9XPJQ	4
POLYGALA SENEGA ROOT	ACTIVE INGREDIENT	M7T6H7D4IF	4
PRUNUS LAUROCERASUS LEAF	ACTIVE INGREDIENT	F26P2D4757	4
RUMEX CRISPUS ROOT	ACTIVE INGREDIENT	9N1RM2S62C	4
VERBASCUM THAPSUS	ACTIVE INGREDIENT	C9TD27U172	4
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	4
DROSERA ROTUNDIFOLIA	ACTIVE MOIETY	QR44N9XPJQ	4
POLYGALA SENEGA ROOT	ACTIVE MOIETY	M7T6H7D4IF	4
PRUNUS LAUROCERASUS LEAF	ACTIVE MOIETY	F26P2D4757	4
RUMEX CRISPUS ROOT	ACTIVE MOIETY	9N1RM2S62C	4
VERBASCUM THAPSUS	ACTIVE MOIETY	C9TD27U172	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	4
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Kids Cough and Fever Relief
Atropa belladonna and Drosera rotundifolia and Prunus laurocerasus leaf and Rumex crispus root and Polygala Senega Root and Verbascum thapsus
ATROPA BELLADONNA
DROSERA ROTUNDIFOLIA
PRUNUS LAUROCERASUS LEAF
RUMEX CRISPUS ROOT
POLYGALA SENEGA ROOT
VERBASCUM THAPSUS
WATER
SORBITOL
SODIUM CHLORIDE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59262-259	59262-259-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
DROSERA ROTUNDIFOLIA	QR44N9XPJQ	ACTIB
PRUNUS LAUROCERASUS LEAF	F26P2D4757	ACTIB
RUMEX CRISPUS ROOT	9N1RM2S62C	ACTIB
POLYGALA SENEGA ROOT	M7T6H7D4IF	ACTIB
VERBASCUM THAPSUS	C9TD27U172	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT

Source Document#

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 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 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	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 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
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	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 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
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 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	GRANULE, FOR SUSPENSION / ORAL		113 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
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 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

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
e62a4ccd-883d-48a0-a399-e870cc8b82a3			b66edb36-f438-4eaf-b7e1-7e291fccd0ec	2013-07-08	Warnings	Exact identifier spl id: e62a4ccd-883d-48a0-a399-e870cc8b82a3 spl set id: b66edb36-f438-4eaf-b7e1-7e291fccd0ec

Reported adverse events (FAERS/openFDA)#

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