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Relax AM-PM (Foster Regal Laboratories)

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TABLET 90 TABLET in 1 BOTTLE (64175-991-90) Label Information

Complete Relax AM-PM Information

  • ACTIVE INGREDIENT

    EACH TABLET CONTAINS: 6 parts Valerian Root (Quad-Strength) 1X, 3 parts Passiflora (Quad-Strength) 1X, 1 part Magnesium Carbonate 1X.
  • PURPOSE

    For Relief of Muscle Spasms
    Tension and Stress
  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental overdose seek professional assistance or contact a poison control center immediately.
  • INDICATIONS & USAGE

    INDICATIONS: For temporary relief of muscle spasms, tension and stress.


  • WARNINGS

    Warning: Do not give to children under twelve except under the advice and supervision of a doctor. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Do not exceed recommended dosage. Consult a doctor if symptoms are more than mild or if they persist.


  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 or more years of age.

    Muscle Spasms - Take 1 or 2 tablets every 3 hours, until relief is obtained. To help prevent recurrence of muscle spasms, continue to take 1 or 2 tablets every 4 hours as needed.

    Tension and Stress - Take 1 or 2 tablets every 4 hours, preferably with meals and at bedtime. To help prevent tension and stress take 1 or 2 tablets every 4 hours as needed.

    Dosage should not exceed 12 tablets in any 24 hour period.


  • INACTIVE INGREDIENT

    Lactose Monohydrate, Maltodextrin, Sodium Starch Glycolate Type A Potato, Stearic Acid, Silica


  • INGREDIENTS AND APPEARANCE
    RELAX AM-PM 
    valerian root, passiflora, magnesium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64175-991
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 6 [hp_X]
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER 3 [hp_X]
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (Magnesium - UNII:I38ZP9992A) MAGNESIUM CARBONATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color brown (brown with dark brown speckels) Score no score
    Shape ROUND (Tablet) Size 11mm
    Flavor Imprint Code 36
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64175-991-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/07/2012
    Labeler - Foster Regal Laboratories (807396481)
    Registrant - Dee Cee Laboratories (034731893)
    Establishment
    Name Address ID/FEI Business Operations
    Dee Cee Laboratories 034731893 manufacture