CALM AND COLLECTED (PIPER METHYSTICUM ROOT) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]

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  • CALM AND COLLECTED (PIPER METHYSTICUM ROOT) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]

CALM AND COLLECTED (PIPER METHYSTICUM ROOT) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]
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NDC 59262-606-30
Set ID b3c63baa-31f4-46d5-8d52-780623dd8f98
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients      

    Piper methysticum (Kava Kava Root) 12X

  • Purpose

    nervousness, restlessness

  • Active Ingredients

    Piper methysticum (Kava Kava Root) 15X

  • Purpose

    nervousness, restlessness

  • Active Ingredients

    Piper methysticum (Kava Kava Root) 30X

  • Purpose

    nervousness, restlessness

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
    • Nervousness
    • Restlessness

  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Do not exceed recommended dosage.

    • Not intended for children under 2.

    If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if:

    symptoms worsen or persist for more than 72 hours

  • Directions Adults and Children ages 2 and older:

    Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Lactose, Magnesium stearate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-606-30
    Similasan
    Calm &
    Collected
    Keva Keva
    Actives
    60 Dissolvable Tablets

    PRINCIPAL DISPLAY PANEL NDC 59262-606-30 Similasan Calm & Collected Keva Keva Actives 60 Dissolvable Tablets

  • INGREDIENTS AND APPEARANCE
    CALM AND COLLECTED 
    piper methysticum root tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP) PIPER METHYSTICUM ROOT57 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-606-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2017
    Labeler - Similasan Corporation (111566530)
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