KIDS 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

Kids Cold and Mucus Relief Plus Echinacea by

Drug Labeling and Warnings

Kids Cold and Mucus Relief Plus Echinacea by is a Homeopathic medication manufactured, distributed, or labeled by Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Belladonna* 6X                        

Purpose

sore throat, cough, mucus

Active Ingredient

Drosera (sundew) 4X                  

Purpose

spasmodic/hacking/tickling cough

Active Ingredient

Echinacea (pale purple coneflower) 6X      

Purpose

immune stimulant

Active Ingredient

Laurocerasus (cherry laurel) 4X            

Purpose

hacking, dry cough

Active Ingredient

Rumex crispus (yellow dock) 4X            

Purpose

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

Active Ingredient

Senega officinalis (mountain flax) 6X      

Purpose

nasal congestion, mucus dry/hacking/tickling cough

Active Ingredient

Verbascum thapsus (common mullein) 6X      

Purpose

hoarse throat, spasmodic cough at night

Active Ingredient

Zincum metallicum (zinc) 12X      

Purpose

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:

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.

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 getinfo@similasanusa.com 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

INGREDIENTS AND APPEARANCE

KIDS 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-266
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]  in 1 mL
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	4 [hp_X]  in 1 mL
ECHINACEA PALLIDA (UNII: 904CK3270L) (ECHINACEA PALLIDA - UNII:904CK3270L)	ECHINACEA PALLIDA	6 [hp_X]  in 1 mL
PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757)	PRUNUS LAUROCERASUS LEAF	4 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	4 [hp_X]  in 1 mL
LINUM CATHARTICUM (UNII: A9L9GRH405) (LINUM CATHARTICUM - UNII:A9L9GRH405)	LINUM CATHARTICUM	6 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	6 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-266-25	1 in 1 BOX	02/01/2016
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2016

Labeler - Similasan AG (481545754)