Label: CALC FLUOR- calcium fluoride tablet

  • NDC Code(s): 54973-2033-1, 54973-2033-2
  • 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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  • 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.

  • PURPOSE

    For Colds, Hemorrhoids, Chapped Skin

    INDICATIONS

    Relief of symptoms of headcolds with thick, greenish discharge. Relieves the symptoms of itching and burning pains due to hemorrhoids. Relieves the symptoms of chapped and cracked skin.

  • ACTIVE INGREDIENT

    Calcarea Fluorica 6X HPUS

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

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Warnings

    Do not use if imprinted cap band is broken or missing. If symptoms persist for more than 7 days or worsen, contact a licensed health care provider.

    If you are pregnant or nursing, seek the advice of a licensed health care provider before using this product.

    Keep all medications out of the reach of children.

  • QUESTIONS?

    800.624.9659

  • PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

    HOMEOPATHIC

    NDC 54973-2033-2

    Hyland's®

    #1

    Calc. Fluor. 6X

    Colds, Hemorrhoids,

    Chapped Skin

    1000 TABLETS

    Label

  • INGREDIENTS AND APPEARANCE
    CALC FLUOR 
    calcium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-2033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-2033-1500 in 1 BOTTLE; Type 0: Not a Combination Product01/01/1940
    2NDC:54973-2033-21000 in 1 BOTTLE; Type 0: Not a Combination Product01/01/194012/27/2021
    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(54973-2033) , pack(54973-2033) , label(54973-2033)
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