Label: GAS RELIEF KIDS RELIEF- colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa 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 September 16, 2010

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  • ACTIVE INGREDIENTS HPUS

    Colocynthis (Bitter apple) 6X

    Magnesia phosphorica (Magnesium hydrogen phosphate) 6X

    Chamomilla (German chamomile) 6X

    Dioscorea villosa (Wild yam) 6X

  • PURPOSE

    Abdominal bloating, colic and nausea.
    Abdominal cramps.
    Nausea, agitation and irritability.
    Intestinal gas, burping and colic-like pain.
  • REFERENCES

    This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).


  • USES

    This homeopathic medicine helps relieve symptoms associated with colic:

    - intestinal gas

    - abdominal pain

    - bloating

    - nausea

    - burping.

  • WARNINGS


    Do not use if seal is broken or missing.

    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

    Keep out of reach of children.

  • DIRECTIONS

    Do not use more than directed.

    Take .75 ml orally at the onset of symptoms.

    Repeat every 15 minutes up to 4 times then reduce with improvement or as directed by a healthcare professional.


    Infants and children 0 to 9 years of age: .75 ml

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Purified water, sorbitol, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    image of carton label

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF KIDS RELIEF 
    colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 25 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]  in 25 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 25 mL
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT6 [hp_X]  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY, GRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9080-81 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/08/2010
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture
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