FDA Label for Kids Cough And Cold Relief Plus Echinacea, Nighttime

View Indications, Usage & Precautions

Kids Cough And Cold Relief Plus Echinacea, Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Similasan Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.