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

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AVENA SATIVA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC 15631-0069-0, 15631-0069-1, 15631-0069-2, 15631-0069-3, 15631-0069-4, 15631-0069-5
Set ID 0d174ce9-262b-44bb-9d23-beccd300374c
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

    AVENA SATIVA HPUS 1X and higher

  • USES

    USES: Temporary Relief - Difficulty Falling Asleep*

    * 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

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

  • PRINCIPAL DISPLAY PANEL

    Mini-Label

    Label-Pellets

    Blister-label

    carton-label

  • INGREDIENTS AND APPEARANCE
    AVENA SATIVA 
    avena sativa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0069
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-0069-0100 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    2NDC:15631-0069-1200 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    3NDC:15631-0069-2400 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    4NDC:15631-0069-3750 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    5NDC:15631-0069-42500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    6NDC:15631-0069-512500 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    7NDC:15631-0069-6500 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
    8NDC:15631-0069-71000 in 1 PACKAGE; Type 0: Not a Combination Product08/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/12/2015
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0069) , label(15631-0069)
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