Label: MOODCALM- hyoscyamus, kali phos, nat sulphuricum, tarentula hisp tablet

  • 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: Hyoscyamus 6C, Kali phos 6X, Nat sulphuricum 6X, Tarentula hisp 6C.

  • Uses*

    Uses*: Homeopathic remedy for acute agittion, restlessness, or over excitement.

  • 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 medicatoin out of reach of children. In case of overdose, ge medical help or contact a Poison Control Center right away.

  • Directions

    Directions: For all ages: Take 2 tablets every 30 minutes. Servings may be repeated as needed for up to 10 servings. Alternatively, for small babies, crush tablets and sprinkle onto tongue.

    Special instructions: Avoid strong mint-flavored candy.

  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact.

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

  • Inactive Ingredients

    Inactive Ingredients: Magnesium stearate, Maltodextrin, 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. 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.

  • PURPOSE

    Calms emotional outbursts & agitation and reduces mood swings. *

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

  • PRINCIPAL DISPLAY PANEL

    MoodCalm Tablets

  • INGREDIENTS AND APPEARANCE
    MOODCALM 
    hyoscyamus, kali phos, nat sulphuricum, tarentula hisp tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-361
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 180 
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA6 [hp_C]  in 180 
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE6 [hp_X]  in 180 
    HYOSCYAMUS NIGER LEAF (UNII: 32IT7G8BAW) (HYOSCYAMUS NIGER LEAF - UNII:32IT7G8BAW) HYOSCYAMUS NIGER LEAF6 [hp_C]  in 180 
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-361-80180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/11/2021
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(68703-361)
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