FDA Label for Kids Stuffy Nose And Sinus
View Indications, Usage & Precautions
Kids Stuffy Nose And Sinus Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Consumer Health Inc.. 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.
Otc - Purpose
Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache
Otc - Active Ingredient
Active ingredients | Purpose |
Calcarea Carbonica 3X HPUS.........................................................................................................sinus pressure, congestion, headache |
Hydrastis Canadensis 6X HPUS .....................................................................................................sinus headache |
Kali Bichromicum 6X HPUS..............................................................................................................nasal congestion, sinus pressure |
Pulsatilla Nigricans 6X HPUS ..........................................................................................................sinus pressure, headache |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses
■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:
■ nasal congestion ■ sinus pressure ■ headache
Stop Use And Ask A Doctor If
■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever.
If Pregnant Or Breastfeeding
Ask a health professional before use.
Directions
■ Use as directed.
Children 4 years
to under 6 years | At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist,
1 tablet every 4 hours until relieved. |
Children 6 years
to under 12 years | At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist,
2 tablets every 4 hours until relieved. |
Adults and children
12 years and over | At onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours. If symptoms persist,
3 tablets every 4 hours until relieved. |
Inactive Ingredients
Acacia Gum, Lactose
Questions?
www.hylands.com or [email protected]
Principal Display Panel
Hyland's
NATURALS™
•Kids•
Stuffy Nose
& Sinus*
NO ARTIFICIAL FLAVORS,
DYES or PARABENS
Nasal Congestion
Sinus Pressure
Headache
4 - 12 YEARS
50
QUICK-DISSOLVING TABLETS
HOMEOPATHIC
* Please review the disclaimer below.