Label at a glance#

ProductKids Cough and Cold Relief Plus Echinacea, Nighttime

Active ingredientATROPA BELLADONNA, MATRICARIA RECUTITA, COPPER, DROSERA ROTUNDIFOLIA FLOWERING TOP, ECHINACEA PALLIDA, FERROSOFERRIC PHOSPHATE, POLYGALA SENEGA ROOT, ZINC

Label structure17 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product provide immunity support and temporarily relieve minor symptoms such as: Cough Mucus Congestion

Dosage and administration

For children age 2 and over: AGE DOSE FREQUENCY 2-12 2.5 ml (½ tsp) 3 to 6 times daily (every 4 hours) 12+ 5 ml (1 tsp) 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X

Purpose

OTC - PURPOSE SECTION

sore throat, nighttime cough, mucus

Active Ingredient

Chamomilla (chamomile) 8X

Purpose

mucus, dry cough, restlessness

Active Ingredient

Cuprum metallicum (copper) 12X

Purpose

hoarseness, mucus, dry cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Drosera (sundew) 4X

Purpose

OTC - PURPOSE SECTION

nighttime spasmodic/hacking/tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Echinacea (pale purple coneflower) 6X

Purpose

OTC - PURPOSE SECTION

immune stimulant

Active Ingredient

Ferrum phosphoricum (iron phosphate) 12X

Purpose

hoarseness, mucus, tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Senega officinalis (mountain flax) 6X

Purpose

OTC - PURPOSE SECTION

nasal congestion, mucus, dry/hacking/tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zincum metallicum (zinc) 12X

Purpose

OTC - PURPOSE SECTION

Roughness/dryness/soreness in throat, tickling cough

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product provide immunity support and temporarily relieve minor symptoms such as:

Cough
Mucus
Congestion

Warnings

WARNINGS SECTION

According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
Do not exceed recommended dosage.
Not intended for children under 2.
A persistent cough may be a sign of a serious condition.
Do not use in case of hypersensitivity/allergy to the ingredients

If pregnant, trying to get pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

symptoms worsen or persist for more than 72 hours
there is a fever of 102°F or greater

Directions

DOSAGE & ADMINISTRATION SECTION

For children age 2 and over:

AGE	DOSE	FREQUENCY
2-12	2.5 ml (½ tsp)	3 to 6 times daily (every 4 hours)
12+	5 ml (1 tsp)	3 to 6 times daily (every 4 hours)

Replace cap tightly after every use
Or use as directed by a licensed health care professional.

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, Natural grape flavor, Purified water, Sorbitol

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

*containing ≤0.0000000016% alkaloids calculated as hyoscyamine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Similasan_®
NIGHTTIME

Kids Cough &
Cold Relief
Plus ECHINACEA
for IMMUNITY SUPPORT
COUGH SYRUP
118 ml / 4 fl oz

PRINCIPAL DISPLAY PANEL Similasan® NIGHTTIME Kids Cough & Cold Relief Plus ECHINACEA for IMMUNITY SUPPORT COUGH SYRUP 118 ml / 4 fl oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53799-265-25	2024-01-30	C162847	48780-1	1030e365-3641-111a-e063-dadaa90a10e2	Kids Cough and Cold Relief Plus Echinacea, Nighttime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53799-265-25	Kids Cough and Cold Relief Plus Echinacea, Nighttime	1 in 1 BOX	SYRUP	1		2
53799-265-25	Kids Cough and Cold Relief Plus Echinacea, Nighttime	118 mL in 1 BOTTLE	SYRUP	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53799-265	KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME (ATROPA BELLADONNA, MATRICARIA RECUTITA, COPPER, DROSERA ROTUNDIFOLIA FLOWERING TOP, ECHINACEA PALLIDA, FERROSOFERRIC PHOSPHATE, POLYGALA SENEGA ROOT AND ZINC) SYRUP [SIMILASAN AG]	2	Legacy NDC, 2 package rows	20220120_944ef64b-3970-432b-b151-e2aea0730374.zip

Products#

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

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

Kids Cough and Cold Relief Plus Echinacea, Nighttime
atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc
ATROPA BELLADONNA
MATRICARIA RECUTITA
COPPER
DROSERA ROTUNDIFOLIA FLOWERING TOP
ECHINACEA PALLIDA
FERROSOFERRIC PHOSPHATE
POLYGALA SENEGA ROOT
ZINC
CITRIC ACID MONOHYDRATE
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53799-265	53799-265-25

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
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
COPPER	789U1901C5	ACTIB
DROSERA ROTUNDIFOLIA FLOWERING TOP	75O014T1HG	ACTIB
ECHINACEA PALLIDA	904CK3270L	ACTIB
FERROSOFERRIC PHOSPHATE	91GQH8I5F7	ACTIB
POLYGALA SENEGA ROOT	M7T6H7D4IF	ACTIB
ZINC	J41CSQ7QDS	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

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
69289980-07fc-49ae-8948-726954bb97b0			944ef64b-3970-432b-b151-e2aea0730374	2022-01-24	Warnings	Exact identifier spl id: 69289980-07fc-49ae-8948-726954bb97b0 spl set id: 944ef64b-3970-432b-b151-e2aea0730374

Reported adverse events (FAERS/openFDA)#

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