Label: CALC FLUOR- calcium fluoride tablet

  • NDC Code(s): 54973-4072-1, 54973-4072-2
  • 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 November 30, 2022

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  • PURPOSE

    Temporarily relieves cold symptoms, chapped or cracked skin, itching or pain due to hemorrhoids

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Calcarea Fluorica 6X HPUScold symptoms, hemorrhoids, chapped and cracked skin

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

  • Uses

    ■Temporarily relieves:
    ■ cold symptoms ■ chapped or cracked skin
    ■ itching or pain due to hemorrhoids

  • Warnings

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,
    consult a doctor promptly.

    Ask a doctor before use if you have

    ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be
    a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if

    ■ bleeding occurs. ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops.

    ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

    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 COUNT BOTTLES CARTON

    Hyland's

    NATURALS ™

    CELL SALT

    # 1

    CALC FLUOR 6X

    Cold Symptoms*

    Hemorrhoids*

    Chapped Skin*

    2 x 50 CT BOTTLES

    QUICK-DISSOLVING SINGLE TABLET DOSES

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    CALC FLUOR 
    calcium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4072
    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
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4072-150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2021
    2NDC:54973-4072-21 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(54973-4072) , pack(54973-4072) , label(54973-4072)
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