CALC FLUOR (CALCIUM FLUORIDE) TABLET [HYLAND'S]

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CALC FLUOR (CALCIUM FLUORIDE) TABLET [HYLAND'S]
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NDC 54973-3101-1, 54973-3101-2
Set ID bc9a8dbc-9d44-4e80-81f4-9fcc718ced01
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
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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

    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.

  • FORMULA

    Calcarea Fluorica 30X 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.

  • PURPOSE

    Colds, Hemorrhoids, Chapped Skin

  • Warnings

    Do not use if imprinted cap band is broken or missing. If symptoms persist for more than seven 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 this and all medications out of the reach of children.

  • QUESTIONS?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

    HOMEOPATHIC

    NDC 54973-3101-1

    Hyland's®

    # 1
    Calc. Fluor. 30X

    Colds, Hemorrhoids,
    Chapped Skin

    500 TABLETS

    Label

  • INGREDIENTS AND APPEARANCE
    CALC FLUOR 
    calcium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [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:54973-3101-1500 in 1 BOTTLE; Type 0: Not a Combination Product01/01/1940
    2NDC:54973-3101-21000 in 1 BOTTLE; Type 0: Not a Combination Product01/01/194012/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1940
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3101)
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