FDA.reportPublic FDA data

Kids Cold and Mucus Relief Plus Echinacea

Manufacturer
Similasan AG
Effective date
2020-09-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:13

Label at a glance#

ProductKids Cold and Mucus Relief Plus Echinacea
Active ingredientATROPA BELLADONNA, DROSERA ROTUNDIFOLIA FLOWERING TOP, ECHINACEA PALLIDA, PRUNUS LAUROCERASUS LEAF, RUMEX CRISPUS ROOT, LINUM CATHARTICUM, VERBASCUM THAPSUS, ZINC
Label structure23 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X                        

Purpose

OTC - PURPOSE SECTION

sore throat, cough, mucus

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Drosera (sundew) 4X                  

Purpose

OTC - PURPOSE SECTION

spasmodic/hacking/tickling cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Echinacea (pale purple coneflower) 6X      

Purpose

OTC - PURPOSE SECTION

immune stimulant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Laurocerasus (cherry laurel) 4X            

Purpose

OTC - PURPOSE SECTION

hacking, dry cough

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Rumex crispus (yellow dock) 4X            

Purpose

OTC - PURPOSE SECTION

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

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

Verbascum thapsus (common mullein) 6X      

Purpose

OTC - PURPOSE SECTION

hoarse throat, spasmodic cough at night

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zincum metallicum (zinc) 12X      

Purpose

OTC - PURPOSE SECTION

roughness/dryness/soreness in throat, cough

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product 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

Directions:

DOSAGE & ADMINISTRATION SECTION

For children age 2 and over:

AGEDOSEFREQUENCY
2-122.5 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, 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®
Kids Cold &
Mucus Relief
Plus ECHINACEA
for IMMUNITY SUPPORT
EXPECTORANT SYRUP
118 ml / 4 fl oz

PRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl ozPRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl oz

PRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl ozPRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-266-252025-01-30C16284748780-12cef2736-adfc-d83d-e063-dadaa90ab31fKids Cold and Mucus Relief Plus Echinacea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-266-25Kids Cold and Mucus Relief Plus Echinacea118 mL in 1 BOTTLESYRUP1182
53799-266-25Kids Cold and Mucus Relief Plus Echinacea1 in 1 BOXSYRUP12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-266KIDS COLD AND MUCUS RELIEF PLUS ECHINACEA (ATROPA BELLADONNA, DROSERA ROTUNDIFOLIA FLOWERING TOP, ECHINACEA PALLIDA, PRUNUS LAUROCERASUS LEAF, RUMEX CRISPUS ROOT, LINUM CATHARTICUM, VERBASCUM THAPSUS AND ZINC) SYRUP [SIMILASAN AG]2Legacy NDC, 2 package rows20230106_6fcbcf79-a720-44ca-a6a3-2aa3ac8a2b46.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-26653799-266-25

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
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
DROSERA ROTUNDIFOLIA FLOWERING TOP75O014T1HGACTIB
ECHINACEA PALLIDA904CK3270LACTIB
PRUNUS LAUROCERASUS LEAFF26P2D4757ACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
LINUM CATHARTICUMA9L9GRH405ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ZINCJ41CSQ7QDSACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
89087072-198c-4897-8ca0-eb1f5fa007156fcbcf79-a720-44ca-a6a3-2aa3ac8a2b462020-09-29WarningsExact identifier
spl id: 89087072-198c-4897-8ca0-eb1f5fa00715
spl set id: 6fcbcf79-a720-44ca-a6a3-2aa3ac8a2b46

Reported adverse events (FAERS/openFDA)#

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