Label: CALC PHOS- tribasic calcium phosphate tablet

  • NDC Code(s): 54973-4073-1, 54973-4073-2
  • Packager: Hyland's Inc.
  • 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 December 7, 2022

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  • PURPOSE

    Gum & Tooth Sensitivity, Teething Pain

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Calcarea Phosphorica 6X HPUSgum and tooth sensitivity, teething pain

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves:
    ■ gum or tooth sensitivity ■ teething pain

  • Warnings

    Stop use and ask a doctor if

    ■ symptoms persist for more than 7 days or worsen. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens.

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.
    ■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or (800) 624-9659

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PACKAGE LABEL - 2 x 50 CT TABLET BOTTLES CARTON

    Hyland's

    NATURALS™

    CELL SALT

    #2

    CALC PHOS 6X

    Gum & Tooth
    Sensitivity*
    Teething Pain*

    2 x 50 CT BOTTLES

    QUICK-DISSOLVING SINGLE TABLET DOSES

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    CALC PHOS 
    tribasic calcium phosphate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4073
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4073-150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2021
    2NDC:54973-4073-21 in 1 CARTON12/06/2021
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/06/2021
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4073) , pack(54973-4073) , label(54973-4073)
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