Kids Cough And Cold Relief Plus Echinacea, Nighttime
FDA Label NDC 53799-265

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 Cough And Cold Relief Plus Echinacea, Nighttime (NDC 53799-265). 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      

Senega officinalis (mountain flax) 6X            

Zincum metallicum (zinc) 12X      

Purpose

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

nighttime spasmodic/hacking/tickling cough

immune stimulant

Active Ingredient

Ferrum phosphoricum (iron phosphate) 12X

Purpose

hoarseness, mucus, tickling cough

nasal congestion, mucus, dry/hacking/tickling cough

Roughness/dryness/soreness in throat, tickling cough

Uses*

According to homeopathic principles, the active ingredients in this product provide immunity support and 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
  • there is a fever of 102°F or greater

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, Natural 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®
NIGHTTIME

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

Principal Display Panelsimilasan®nighttimekids Cough &cold Reliefplus Echinaceafor Immunity Supportcough Syrup118 mL / 4 Fl Oz (Kids Cough And Cold Relief Plus Echinacea Nighttim 01)

Principal Display Panelsimilasan®nighttimekids Cough &cold Reliefplus Echinaceafor Immunity Supportcough Syrup118 mL / 4 Fl Oz (Kids Cough And Cold Relief Plus Echinacea Nighttim 01)

Principal Display Panelsimilasan®nighttimekids Cough &cold Reliefplus Echinaceafor Immunity Supportcough Syrup118 mL / 4 Fl Oz (Kids Cough And Cold Relief Plus Echinacea Nighttim 02)

Principal Display Panelsimilasan®nighttimekids Cough &cold Reliefplus Echinaceafor Immunity Supportcough Syrup118 mL / 4 Fl Oz (Kids Cough And Cold Relief Plus Echinacea Nighttim 02)

* Please review the disclaimer below.