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CALM-ITO (Nartex Laboratorios Homeopaticos, S.A. De C.V.)

Available Formats

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TABLET 100 TABLET in 1 BOTTLE (34666-005-10) Label Information

Complete CALM-ITO Information

  • ACTIVE INGREDIENT

    Chamomilla.................3X HPUS

    Coffea Cruda...............3X HPUS

    Cypripedium................3X HPUS

    Hyoscayamus...............3X HPUS


  • PURPOSE

    Chamomilla.................3X HPUS*.............Oversensitivity and sleeplessness

    Coffea Cruda...............3X HPUS*........................Anxiety and sleeplessness

    Cypripedium................3X HPUS*................................Nervousness in kids

    Hyoscayamus...............3X HPUS*.....................Insomnia, scaared wake-up

    *The letters "HPUS" indicate that hte components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. X is an homeopathic dilution. See www.nartexlabsusa.com for more information. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.


  • INDICATIONS & USAGE

    Helps relieve symptoms such as:

    • irritability
    • crying
    • oversensitivity
    • restlessness
    • sleeplessness

    as per Materia Medica

    Product uses are based on Homeopathic Materia Medica. These "Uses" have not been evaluated by the Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.


  • WARNINGS

    Do not use

    • if you have an allergy or hypersensitivity to components of the formulathis product except under advise and supervision of a physician
    • if you are allergic to milk or milk products

    Stop use and ask a physician if

    • discomfort persists for more than 8 hours
    • If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical issues

    Avoid

    • alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor

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


  • DOSAGE & ADMINISTRATION

    • adults and children over 2 years take 3 tablets every 4 hours

  • STORAGE AND HANDLING

    store in a cool and dry place


  • INACTIVE INGREDIENT

    Citric acid, lactose, magnesium stearate, sodium benzoate, sucrose


  • QUESTIONS

    informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST


  • DESCRIPTION

    Distributed by:

    Nartex Labs USA, Inc.

    11711 Memorial Dr. #685

    Houston TX 77024

    www.nartexlabsusa.com


  • DESCRIPTION

    Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.

    Keep carton. It contains important information.

    For your protection, this bottle has a seal around the neck. Attention: do not use if the neck seal is broken.

    This product is HOMEOPATHIC. Its claims and efficacy are based on homeopathic research and clinical experience. This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs. For more information on homeopathy vists www.nartexlabsusa.com before using this product.


  • PRINCIPAL DISPLAY PANEL

    NDC 34666-005-10

    Calmito

    Coffea cruda Cypripedium Hyoscyamus Chamomilla

    Children irritability*

    tablets

    Homeopathic

    Directions

    Take 3 tablets every 4 hours**

    Grape flavor

    100 tablets

    *BASED ON HOMEOPATHIC MATERIA MEDICA

    **SEE DIRECTIONS AT THE BACK

    CalmitoCarton


  • INGREDIENTS AND APPEARANCE
    CALM-ITO 
    coffea cruda, cypripendium, hyoscyamus and matricaria chamomilla tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:34666-005
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744) COFFEE BEAN 3 [hp_X]
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT 3 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X]
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code none
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:34666-005-10 1 in 1 PACKAGE 08/01/2009
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/01/2009
    Labeler - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)
    Registrant - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)
    Establishment
    Name Address ID/FEI Business Operations
    Nartex Laboratorios Homeopaticos, S.A. de C.V. 589914576 manufacture(34666-005)