Label: CALOTROPIS GIGANTEA pellet

  • 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 February 19, 2020

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  • ACTIVE INGREDIENT

    CALOTROPIS GIGANTEA HPUS 1X and higher

  • USES

    Fever & Vomiting

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.

    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    Sucrose

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CALOTROPIS GIGANTEA 
    calotropis gigantea pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALOTROPIS GIGANTEA ROOT (UNII: 17B4I9SE7R) (CALOTROPIS GIGANTEA ROOT - UNII:17B4I9SE7R) CALOTROPIS GIGANTEA ROOT1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-0102-0100 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    2NDC:15631-0102-1200 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    3NDC:15631-0102-2400 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    4NDC:15631-0102-3750 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    5NDC:15631-0102-42500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    6NDC:15631-0102-512500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/06/2015
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0102) , label(15631-0102)
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