Label: GAS AND COLIC PLUS STOMACH CRAMPS BABY- anamirta cocculus whole, citrullus colocynthis fruit pulp, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate and matricaria chamomilla tablet, orally disintegrating

  • 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 July 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Chamomilla 12Xstomach pressure, gas, irritability, sleeplessness, crying
    Cocculus indicus 15Xstomach cramps, colic, flatulence, disturbed sleep
    Colocynthis 12Xcramps, stomach pressure and pain, sleeplessness, bloating
    Lycopodium 15Xflatulence, bloating, colic (esp. evenings), irritability, restlessness
    Magnesia phosphorica 12Xstomach cramps, hiccups
  • Uses1

    According to homeopathic principles, the active ingredients in this product temporarily relieve the symptoms associated with gas, colic and stomach cramps caused by irritating food, feeding too quickly, swallowing air and similar conditions.

    1
    These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration
  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
    • If conditions worsen or persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.
    • Consult a physician if the following symptoms occur: vomiting, change in stool, fever, lethargy, or poor weight gain.
    • Do not exceed recommended dosage.
    • As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

  • Directions

    Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

  • Other information

    Active ingredients are manufactured according to homeopathic principles.

    Do not use if tamper evident seal beneath cap is broken or missing.

    For more information, see http://www.similasanUSA.com/about-homeopathy

  • Inactive ingredients

    Crospovidone, Mannitol, Sodium stearyl fumarate

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Similasan Corp., Highlands Ranch, CO 80129

  • PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Carton

    NDC 59262-503-26

    Similasan®

    Gas & Colic
    + Stomach
    Cramps

    Formulated with
    NATURAL ACTIVE INGREDIENTS
    BABY

    • Chamomile for Irritability*
    • Salt of Magnesia for Stomach Cramps*
    • No Artificial Flavors, Dyes or Preservatives

    HOMEOPATHIC
    Based on Original
    Swiss Formula

    135 Quick Dissolving
    Tablets (actual size)

    PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    GAS AND COLIC PLUS STOMACH CRAMPS BABY 
    anamirta cocculus whole, citrullus colocynthis fruit pulp, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate and matricaria chamomilla tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-503
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Matricaria Chamomilla (UNII: G0R4UBI2ZZ) (Matricaria Chamomilla - UNII:G0R4UBI2ZZ) Matricaria Chamomilla12 [hp_X]
    Anamirta Cocculus Whole (UNII: 8O4P2U3QO2) (Anamirta Cocculus Whole - UNII:8O4P2U3QO2) Anamirta Cocculus Whole15 [hp_X]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP12 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Crospovidone, Unspecified (UNII: 2S7830E561)  
    Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI)  
    Mannitol (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-503-261 in 1 BOX07/20/2018
    1135 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/15/2018
    Labeler - Similasan Corporation (111566530)
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