Otc - Purpose
Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache
Kids Stuffy Nose And Sinus Tablet
FDA Label NDC 54973-4115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Consumer Health Inc. for the product Kids Stuffy Nose And Sinus (NDC 54973-4115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, uses, stop use and ask a doctor if, if pregnant or breastfeeding, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Carton (Ssfkt50 Carton)
* Please review the disclaimer below.
