Label: TULA TANTRUM TAMER- chamomilla, cina 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 December 25, 2023

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal parts of each ingredient in a 6C potency: Chamomilla, Cina.

  • Uses*

    Uses*: Homeopathic remedy for tantrums in young children

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

  • Warnings

    Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions For all ages: Take 5 pilules 2 times daily. Alternatively, for small babies, crush pilules onto tongue.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colorants. No gluten added. Lactose-free.

    Tamper resistant for your protection. Use only if safetey seal is in tact.

  • Inactive Ingredients

    Inactive Ingredients: Organic Sucrose

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • PURPOSE

    Reduces restlessness & tantrums in children

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

  • PRINCIPAL DISPLAY PANEL

    Tula Tantrum Tamer Granules img

  • INGREDIENTS AND APPEARANCE
    TULA TANTRUM TAMER 
    chamomilla, cina pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-365
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER6 [hp_C]  in 26 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 26 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeROUND (roughly spherical) Size3mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-365-2026 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/22/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/22/2021
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(68703-365)
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