Label: BELLY CALM- arg nit, asafoetida, carbo veg, chamomilla, lycopodium, mag phos, nat phos, nux mosch, zingiber. 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

If you are a consumer or patient please visit this version.

  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingredient in a 6C potency: Arg nit, Asafoetida, Carbo veg, Chamomilla, Lycopodium, Mag phos, Nat phos, Nux mosch, Zingiber.

    The letters HPUS indicate that the components in this product are offically momographed in the Homeopathic Pharmacopoeia of the United States.

  • Uses*

    Uses*: Homeopathic relief from upset stomach, diarrhea, gas & bloating, and nervous stomach in 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 Poison Control Center right away.

  • Directions

    Directions: Chew or dissolve tablets in the mouth. For children 2-6 years: 1 tablet, 7-12 years: 2 tablets, 13+ years: 3 tablets. Dose every 15 minutes up to 6 doses, then every 4 hours until relieved.

  • OTHER SAFETY INFORMATION

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

  • Inactive Ingredients

    Inactive ingredients: Magnesium Stearate, Maltodextin, Sucrose.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Temporarily relieves discomfort caused by nervous tummy, upset stomach, diarrhea, gas & bloating.*

  • PRINCIPAL DISPLAY PANEL

    Belly Calm

  • INGREDIENTS AND APPEARANCE
    BELLY CALM 
    arg nit, asafoetida, carbo veg, chamomilla, lycopodium, mag phos, nat phos, nux mosch, zingiber. tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-383
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT6 [hp_C]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_C]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG6 [hp_C]
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER6 [hp_C]
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_C]
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC6 [hp_C]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize3mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-383-80180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/17/2022
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma030572478manufacture(68703-383)