Active Ingredients
Calcarea Carbonica 3X HPUS
Hydrastis Canadensis 6X HPUS
Kali Bichromicum 6X HPUS
Pulsatilla Nigricans 6X HPUS
"HPUS" indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States.
4 Kids Stuffy Nose And Sinus Tablet
FDA Label NDC 54973-3406
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 Inc. for the product 4 Kids Stuffy Nose And Sinus (NDC 54973-3406). 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 active ingredients, purpose, uses, warnings, other, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
sinus pressure, congestion, headache
sinus headache
nasal congestion, sinus pressure
sinus pressure, headache
Uses
- Temporarily relieves symptoms of stuffy nose and sinus in children, including:
- nasal congestion
- sinus pressure
- headache
Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Other
Do not use more than directed.
- Consult a physician if:
- symptoms persist for more than 72 hours or worsen.
- symptoms are accompanied by a high fever (over 101°F).
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Directions
Children 2 years to under 6 years | Dissolve 1 tablet under tongue every 4 hours until relieved, up to 72 hours. |
Children 6 years to under 12 years | Dissolve 2 tablets under tongue every 4 hours until relieved, up to 72 hours. |
Adults and children 12 years and over | Dissolve 3 tablets under tongue every 4 hours until relieved, up to 72 hours. |
Other Information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
- The inner packaged bottle is child-resistant.
Inactive Ingredients
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel
HOMEOPATHIC
NDC 54973-3406-1
2-12
YEARS
NEW
4 KIDS
SINCE 1903
Hyland's
Stuffy Nose
& Sinus*
Relieves nasal congestion,
sinus preasure and headache
NO ARTIFICIAL FLAVORS
NO DYES or PARABENS
NATURAL
RELIEF
50 QUICK-DISSOLVING
TABLETS
*SEE NOTE ON BACK
PANEL BELOW DRUG FACTS
* Please review the disclaimer below.
