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 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
Chamomilla (chamomile) 8X
Cuprum metallicum (copper) 12X
Drosera (sundew) 4X
Echinacea (pale purple coneflower) 6X
Ferrum phosphoricum (iron phosphate) 12X
Senega officinalis (mountain flax) 6X
Zincum metallicum (zinc) 12X
Purpose
sore throat, nighttime cough, mucus
mucus, dry cough, restlessness
hoarseness, mucus, dry cough
nighttime spasmodic/hacking/tickling cough
immune stimulant
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 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:
| 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 [email protected] www.SimilasanUSA.com
*containing 0.0000000016% alkaloids calculated as hyoscyamine
Principal Display Panel
NDC 59262-265-25
Similasan®
NIGHTTIME
Kids Cough &
Cold Relief
Plus ECHINACEA
for IMMUNITY SUPPORT
COUGH SYRUP
118 ml / 4 fl oz
* Please review the disclaimer below.