Label: BABY TEETHING PLUS TOOTH SUPPORT- oyster shell calcium carbonate, crude, calcium fluoride, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, and podophyllum tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 15, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Calcarea carbonica 12X

  • Purpose

    pain, difficult dentition

  • Active Ingredient

    Calcarea fluorica 12X

  • Purpose

    supports dental development

  • Active Ingredient

    Calcarea phosphorica 12X

  • Purpose

    supports dental development, pain, slow dentition

  • Active Ingredient

    Chamomilla 8X

  • Purpose

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

  • Active Ingredient

    Ferrum phosphoricum 12X      

  • Purpose

    fussiness or restlessness

  • Active Ingredient

    Podophyllum peltatum 12X

  • Purpose

    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 getinfo@similasanusa.com.

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

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

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

  • INGREDIENTS AND APPEARANCE
    BABY TEETHING PLUS TOOTH SUPPORT 
    oyster shell calcium carbonate, crude, calcium fluoride, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, and podophyllum tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-500-261 in 1 BOX
    1135 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2015
    Labeler - Similasan Corporation (111566530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Similasan Corporation111566530MANUFACTURE(59262-500)
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