Label: CALCIUM SULPHATE- calcium sulfate tablet

  • NDC Code(s): 54973-2049-1, 54973-2049-2
  • Packager: Hyland's Inc.
  • Category: HUMAN OTC DRUG LABEL

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

    INDICATIONS

    Relief of symptoms of colds with yellow discharge and post nasal drip. Relief of symptoms of sore throat. Relief of symptoms of pimples and blemishes associated with common acne.

  • ACTIVE INGREDIENT

    FORMULA

    Calcarea Sulphurica 6X HPUS in a base of Acacia Gum, Lactose N.F.

  • 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.

    Discontinue use if symptoms are accompanied by a high fever (over 101°F).

    Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

    Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

    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 - 500 Tablet Bottle Label

    HOMEOPATHIC

    NDC 54973-2049-01

    Hyland's®

    #3

    Calc. Sulph. 6X

    Colds, Sore Throat,
    Acne

    500 TABLETS

    Principal Display Panel - 500 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    CALCIUM SULPHATE 
    calcium sulfate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-2049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFATE (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE6 [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:54973-2049-1500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1940
    2NDC:54973-2049-21000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/194012/28/2021
    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(54973-2049) , pack(54973-2049) , label(54973-2049)
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