Label: TUMMY CALM (carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla- smilax regelii, zingiber officinale liquid

  • 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 October 27, 2021

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

  • ACTIVE INGREDIENTS:

    Carbo Vegetabilis 1X, Chamomilla 3X, Lycopodium Clavatum 3X, Nux Moschata 3X, Passiflora Incarnata 3X, Raphanus Sativus 3X,

    Sarsaparilla (Smilax Regelii) 3X, Zingiber Officinale 3X.

  • PURPOSE:

    Temporarily relieves the symptoms of pediatric:

    digestive discomfort • gas • hiccups • reflux

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

  • WARNINGS:

    Do not use if outer seal on glass bottle or protective wrap on oral dispenser is broken or missing.

    Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs.

    • As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

    • Because product is black, a temporary, harmless, darkening of the stool may occur.

    • May stain fabric; protect clothing and furniture.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

            Weight      Dose
    Under 20 lbs. (9kg)      1/4 teaspoon (1.25 mL)
    Over 20 lbs. (9kg)        1/2 teaspoon (2.5 mL)

    • Remove outer seal from glass bottle and protective wrap from oral dispenser.

    • Shake well before use.

    • Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums.

    • If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours.

    • Recap bottle and clean dispenser after use.

    • Discard remaining product after 3 weeks.

  • INDICATIONS:

    Temporarily relieves the symptoms of pediatric:

    digestive discomfort • gas • hiccups • reflux

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

  • OTHER INFORMATION:

    • Please note: sleep may follow naturally after relief.

    • Store at room temperature, out of direct sunlight.

  • INACTIVE INGREDIENTS:

    Citric Acid, Glycerin, Potassium Benzoate, Potassium Citrate, Potassium Sorbate, Purified Water, Xylitol

  • QUESTIONS:

    Distributed by CalmCo LLC

    1215 Sarasota Center Blvd. Sarasota FL 34240

    Call 941-203-4590 visit www.tummycalm.com

  • PACKAGE LABEL DISPLAY:

    Tummy Calm

    For symptomatic relief of

    Gas, Upset Stomach,

    & Reflux

    CalmcCo.

    Homeopathic Medicine

    2 FL. Oz. (59 mL)

    24-47 doses

    Tummy Calm lbl

    Tummy Calm ctn

  • INGREDIENTS AND APPEARANCE
    TUMMY CALM 
    carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE3 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 1 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG3 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
    RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH3 [hp_X]  in 1 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT3 [hp_X]  in 1 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0005-11 in 1 CARTON10/27/2021
    159 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/27/2021
    Labeler - CalmCo LLC (079308308)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(73282-0005) , api manufacture(73282-0005) , label(73282-0005) , pack(73282-0005)