BABY GAS AND COLIC PLUS STOMACH CRAMPS (ATROPA BELLADONNA, MATRICARIA RECUTITA, ANAMIRTA COCCULUS WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET,

BABY GAS AND COLIC PLUS STOMACH CRAMPS (ATROPA BELLADONNA, MATRICARIA RECUTITA, ANAMIRTA COCCULUS WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET,
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NDC 59262-501-26
Set ID ffcfc152-3232-4a88-9b78-e6981fc87684
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Belladonna 12X

  • Purpose

    stomach pressure, abdominal pain, gas

  • Active Ingredient

    Chamomilla 12X

  • Purpose

    gas, colic, irritability, sleeplessness, crying

  • Active Ingredient

    Cocculus indicus 15X

  • Purpose

    stomach cramps, colic, flatulence, disturbed sleep

  • Active Ingredient

    Colocynthis 12X

  • Purpose

    cramps, stomach pressure and pain, sleeplessness

  • Active Ingredient

    Magnesia phosphorica 12X

  • Purpose

    stomach cramps, gas, hiccups, burping, bloating

  • Uses:

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

    • gas discomfort
    • colic
    • stomach cramps
    • stomach pressure
    • hiccups
    • crying
    • irritability
  • Warnings:

    • Initial exacerbation of symptoms may occur.
    • 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.
    • Consulta 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.

  • Inactive Ingredients:

    Kollidon CL, Mannitol, Sodium stearyl fumarate

  • Questions?

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

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-501-26
    Similasan
    ®
    Gas & Colic +
    Stomach Cramps

    BABY

    135 Quick Dissolving
    Tablets

    PRINCIPAL DISPLAY PANEL
NDC 59262-501-26
Similasan®
Gas & Colic +
Stomach Cramps
BABY
135 Quick Dissolving 
Tablets

  • INGREDIENTS AND APPEARANCE
    BABY GAS AND COLIC PLUS STOMACH CRAMPS 
    atropa belladonna, matricaria recutita, anamirta cocculus whole, citrullus colocynthis fruit pulp and magnesium phosphate, dibasic trihydrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [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]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-501-261 in 1 BOX
    1135 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2015
    Labeler - Similasan Corporation (111566530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Similasan Corporation111566530MANUFACTURE(59262-501)

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