FDA Label for Kids Cold And Mucus Relief Plus Echinacea

View Indications, Usage & Precautions

Kids Cold And Mucus Relief Plus Echinacea Product Label

The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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      

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
  • Immunity Support

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



NDC 59262-266-25
Similasan®
Kids Cold &
Mucus Relief
Plus ECHINACEA
for IMMUNITY SUPPORT
EXPECTORANT SYRUP
118 ml / 4 fl oz


* Please review the disclaimer below.