GAS AND COLIC KIDS RELIEF (COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA) LIQUID [HOMEOLAB USA INC]

GAS AND COLIC KIDS RELIEF (COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA) LIQUID [HOMEOLAB USA INC]
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NDC 60512-9083-8
Set ID 7268793e-e3e5-4e3c-bed2-0531e1b91b20
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
  • 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

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

    RETAIN CARTON FOR COMPLETE INSTRUCTIONS

  • Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with colic*:

    • intestinal gas

    • abdominal pain

    • bloating

    • nausea

    • burping

  • Warnings


    Do not use if imprinted shrink seal neckband 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

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

    Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

  • 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 AND COLIC KIDS RELIEF 
    colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9083
    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:60512-9083-81 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/22/2011
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9083)

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