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  5. Label Information: Baby Gum Relief

FDA Label for Baby Gum Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES*
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS:
    7. OTHER INFORMATION:
    8. INACTIVE INGREDIENTS:
    9. QUESTIONS?
    10. PRINCIPAL DISPLAY PANEL

Baby Gum Relief Product Label

The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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.

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


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.