KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME- atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc syrup

Kids Cough and Cold Relief Plus Echinacea, Nighttime by

Drug Labeling and Warnings

Kids Cough and Cold Relief Plus Echinacea, Nighttime 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, nighttime cough, mucus

Active Ingredient

Chamomilla (chamomile) 8X

Purpose

mucus, dry cough, restlessness

Active Ingredient

Cuprum metallicum (copper) 12X

Purpose

hoarseness, mucus, dry cough

Active Ingredient

Drosera (sundew) 4X                  

Purpose

nighttime spasmodic/hacking/tickling cough

Active Ingredient

Echinacea (pale purple coneflower) 6X      

Purpose

immune stimulant

Active Ingredient

Ferrum phosphoricum (iron phosphate) 12X

Purpose

hoarseness, mucus, tickling cough

Active Ingredient

Senega officinalis (mountain flax) 6X            

Purpose

nasal congestion, mucus, dry/hacking/tickling cough

Active Ingredient

Zincum metallicum (zinc) 12X      

Purpose

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:

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, Natural 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®
NIGHTTIME

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

INGREDIENTS AND APPEARANCE

KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME 
atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-265
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
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	8 [hp_X]  in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	12 [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
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 mL
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF)	POLYGALA SENEGA ROOT	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: 53799-265-25	1 in 1 BOX	01/18/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2022

Labeler - Similasan AG (481545754)