Baby Teething Plus Tooth Support
FDA Label NDC 59262-500

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 Teething Plus Tooth Support (NDC 59262-500). 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 ingredient, 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

Active Ingredient

Calcarea carbonica 12X

Calcarea fluorica 12X

Calcarea phosphorica 12X

Chamomilla 8X

Ferrum phosphoricum 12X      

Podophyllum peltatum 12X

Purpose

pain, difficult dentition

supports dental development

supports dental development, pain, slow dentition

swelling, irritability, restlessness, sleeplessness, red cheek/face

fussiness or restlessness

drooling, chewing on things, irritability

Uses:

According to the homeopathic principles, the active ingredients in this product:

  • temporarily relieve restlessness & irritability due to painful gums
  • support dental development

Warnings:

  • Initial exacerbation of symptoms may occur.
  • 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.

Inactive Ingredients:

Kollidon CL, Mannitol, Sodium stearyl fumarate 

Questions?

Reach our representatives at 1-800-240-9780 or [email protected].

www.SimilasanUSA.com

Principal Display Panel

NDC 59262-500-26
Similasan®
Teething +
Tooth Support
BABY
135 Quick Dissolving
Tablets

Principal Display Panelndc 59262-500-26similasan®teething +tooth Supportbaby135 Quick Dissolving Tablets (Baby Teething Plus Tooth Support 01)

Principal Display Panelndc 59262-500-26similasan®teething +tooth Supportbaby135 Quick Dissolving Tablets (Baby Teething Plus Tooth Support 01)

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