Label: CALC PHOS- calcium phosphate tablet

  • NDC Code(s): 54973-2043-1, 54973-2043-2, 54973-2043-3
  • 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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  • DIRECTIONS

    Adults & Children ages 6 - 12:

    4 tablets.

    Children ages 2 - 6:

    2 tablets. Dissolve under tongue

    3 times a day. Use more frequently

    (every 15 minutes for up to 8 doses)

    with acute conditions.

  • INDICATIONS

    Temporarily relieves symptoms of gum or tooth sensitivity.

  • FORMULA

    Calcarea Phosphorica 6X HPUS

    in a base of Acacia Gum, Lactose N.F.

  • SPL UNCLASSIFIED SECTION

    "HPUS" indicates that the active

    ingredients are in the official

    Homeopathic Pharmacopœia of the

    United States.

  • WARNINGS

    As with any drug, ask a doctor before use if pregnant or breast feeding.

    Do not use more than directed.

    Consult a physician if

    • symptoms persist for more than 72 hours or worsen.
    • swelling increases, rash or fever develops.
    • irritation,pain or rednes persists or worsens.

    Keep this and all medications out of the reach of children.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing.

    In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours, a day 7 days per week at (800) 624-9659.

  • QUESTIONS?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

    HOMEOPATHIC

    NDC 54973-2043-01

    Hyland's®

    #2

    Calc Phos 6X

    Gum & Tooth

    Sensitivity*

    500 TABLETS

    label

  • INGREDIENTS AND APPEARANCE
    CALC PHOS 
    calcium phosphate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-2043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-2043-1500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2013
    2NDC:54973-2043-21000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/201312/28/2021
    3NDC:54973-2043-3250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/201312/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1940
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-2043) , pack(54973-2043) , label(54973-2043)
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