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Calmex (Nartex Laboratorios Homeopaticos, S.A. De C.V.)

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TABLET 30 TABLET in 1 BLISTER PACK (34666-003-30) Label Information

Complete Calmex Information

  • ACTIVE INGREDIENT

    Ignatia Amara 3X

    Kali Phsphoricum 6X

    Passiflora Incarnata 3X

    Valeriana Officinalis 3X


  • PURPOSE

    Ignatia Amara 3X............Sleelessness, worry
    Kali Phsphoricum 6X........Asthenia, physical and mental exhaustion, nervousness
    Passiflora Incarnata 3X.....Nervousness, sleeplessness
    Valeriana Officinalis 3X.....Sleeplessness


  • INDICATIONS & USAGE

    Provides temporary relief from symptoms of sleeplessness and restlessness due to worry or stress as per Materia Medica.


  • WARNINGS

    Stop use and ask a doctor if discomfort persists.

    Do not use if you have

    an allergy or hypersensitivity to components of the formula.

    Do not give to children under 12 years of age.


    If sleeplessness persists continuously for more than 2 weeks
    consult your doctor, insomnia may be a symptom of a serious underlying medical illness.

    If pregnant or breast feeding ask a health professional before use.

    Keep out of the reach of children.


  • DOSAGE & ADMINISTRATION

    Adults take 2 tablets orally every 4 hours during the day. Dissolves slowly in mouth.


  • STORAGE AND HANDLING

    Store in a cool and dry place. 


  • INACTIVE INGREDIENT

    Grenetina, lactose, magnesium stearate, potato starch, talc, yellow no. 5


  • QUESTIONS

    P.O. Box 1261, Downey, CA 90240 www.nartexlabs.com


  • PRINCIPAL DISPLAY PANEL

    Homeopathic Medicine

    Calmex

    Passiflora Incarnata
    Ignatia Amara
    Valeriana Officinalis
    Kali Phosphoricum

    Mexican Tradition

    30 Tablets

    Relieves symptoms of sleeplessness, restlessness, and stress

    calmex


  • INGREDIENTS AND APPEARANCE
    CALMEX 
    ignatia amara, kali phosphoricum, passiflora incarnata, valeriana officinalis tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:34666-003
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 3 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color yellow (yellow) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code halfcircles
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:34666-003-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/01/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/01/2009
    Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Establishment
    Name Address ID/FEI Business Operations
    NARTEX LABORATORIOS HOMEOPATICOS SA DE CV 589914576 manufacture(34666-003)