Active Ingredients
Calcarea carbonica (Calcium) 12X
Calcarea fluorica (Calcium) 12X
Calcarea phosphorica (Calcium) 12X
Chamomilla (Chamomile) 8X
Ferrum phosphoricum 12X
Podophyllum peltatum (May Apple) 12X
Baby Gum Relief
FDA Label NDC 59262-502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Baby Gum Relief (NDC 59262-502). 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, keep out of reach of children., directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
pain, difficult dentition
supports dental development
supports dental development, pain, slow dentition
swelling, irritability, restlessness, sleeplessness, red cheek/face
pain
drooling, chewing on things, irritability, fussiness or restlessness
Uses*
According to the homeopathic principles, the active ingredients in this product:
• temporarily relieve restlessness & irritability due to painful gums
• support dental development
Warnings
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.
• Do not exceed recommended dosage.
• As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a medical professional or a poison control center immediately.
Directions:
Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.
Other Information:
Active ingredients are manufactured according to homeopathic principles.
Do not use if tamper evident seal beneath cap is broken or missing.
For more information, see http://www.similasanUSA.com/about-homeopathy
Inactive Ingredients:
Crospovidone, Mannitol, Sodium stearyl fumarate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
Principal Display Panel
NDC 59262-502-26
Baby Gum
Relief
Quick Dissolving Tablets
135 Quick Dissolving
Tablets (actual size)
* Please review the disclaimer below.
