PULSATILLA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]

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PULSATILLA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC 15631-0357-0, 15631-0357-1, 15631-0357-2, 15631-0357-3, 15631-0357-4, 15631-0357-5
Set ID d8607ae4-3fbb-4c0a-9b3b-d9b6ad671c73
Category HUMAN OTC DRUG LABEL
Packager Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    PULSATILLA HPUS 1X and higher

  • USES

    USES: Temporary Relief - Congested Nose, Pms*

    * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • 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

  • INACTIVE INGREDIENTS

    Sucrose

  • QUESTIONS OR COMMENTS

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

    Rxhomeo, Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA

  • PRINCIPAL DISPLAY PANEL

    Mini-Label

    Label-Pellets

    Blister-Pack

    Carton-Pack

  • INGREDIENTS AND APPEARANCE
    PULSATILLA 
    pulsatilla pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0357
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-0357-0100 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    2NDC:15631-0357-1200 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    3NDC:15631-0357-2400 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    4NDC:15631-0357-3750 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    5NDC:15631-0357-42500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    6NDC:15631-0357-512500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    7NDC:15631-0357-6500 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
    8NDC:15631-0357-71000 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/14/2015
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0357) , label(15631-0357)
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