Kids Cold And Mucus Relief Plus Echinacea
FDA Label NDC 53799-266

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Similasan Ag for the product Kids Cold And Mucus Relief Plus Echinacea (NDC 53799-266). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, if pregnant, trying to get pregnant or breast feeding,, keep out of reach of children., stop use and ask a doctor if, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Belladonna* 6X                        

Drosera (sundew) 4X                  

Echinacea (pale purple coneflower) 6X      

Laurocerasus (cherry laurel) 4X            

Rumex crispus (yellow dock) 4X            

Senega officinalis (mountain flax) 6X      

Verbascum thapsus (common mullein) 6X      

Zincum metallicum (zinc) 12X      

Purpose

sore throat, cough, mucus

spasmodic/hacking/tickling cough

immune stimulant

hacking, dry cough

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

nasal congestion, mucus dry/hacking/tickling cough

hoarse throat, spasmodic cough at night

roughness/dryness/soreness in throat, cough

Uses:

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

  • Cough
  • Mucus
  • Congestion

Warnings:

  • 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,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Stop Use And Ask A Doctor If

symptoms worsen or persist for more than 72 hours

Directions:

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:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Citric acid, Grape flavor, Purified water, Sorbitol

Questions? Reach our representatives at 1-800-240-9780 or [email protected] www.SimilasanUSA.com

*containing 0.0000000016% alkaloids calculated as hyoscyamine

Principal Display Panel

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

Principal Display Panelsimilasan®kids Cold &mucus Reliefplus Echinaceafor Immunity Supportexpectorant Syrup118 mL / 4 Fl Oz (Kids Cold And Mucus Relief Plus Echinacea 01)

Principal Display Panelsimilasan®kids Cold &mucus Reliefplus Echinaceafor Immunity Supportexpectorant Syrup118 mL / 4 Fl Oz (Kids Cold And Mucus Relief Plus Echinacea 01)

Principal Display Panelsimilasan®kids Cold &mucus Reliefplus Echinaceafor Immunity Supportexpectorant Syrup118 mL / 4 Fl Oz (Kids Cold And Mucus Relief Plus Echinacea 02)

Principal Display Panelsimilasan®kids Cold &mucus Reliefplus Echinaceafor Immunity Supportexpectorant Syrup118 mL / 4 Fl Oz (Kids Cold And Mucus Relief Plus Echinacea 02)

* Please review the disclaimer below.