Label: RELAX AM-PM- valerian root, passiflora, magnesium carbonate tablet

  • NDC Code(s): 64175-991-25, 64175-991-45, 64175-991-90
  • Packager: Foster Regal Laboratories
  • 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 December 29, 2020

If you are a consumer or patient please visit this version.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Image of Label

  • INGREDIENTS AND APPEARANCE
    RELAX AM-PM 
    valerian root, passiflora, magnesium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64175-991
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER3 [hp_X]
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorbrown (brown with dark brown speckels) Scoreno score
    ShapeROUND (Tablet) Size11mm
    FlavorImprint Code 36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64175-991-9090 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
    2NDC:64175-991-4545 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
    3NDC:64175-991-25250 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/16/2011
    Labeler - Foster Regal Laboratories (807396481)
    Registrant - Dee Cee Laboratories (034731893)