Label: FORMULA 303- valerian root, passiflora, magnesium carbonate tablet

  • NDC Code(s): 52301-303-12, 52301-303-21, 52301-303-25, 52301-303-30, view more
    52301-303-45, 52301-303-60, 52301-303-90
  • Packager: Dee Cee 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.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older, take as directed or as directed by your doctor. Do not exceed 12 tablets in a 24 hour period.

    MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two at bedtime.

    TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.

  • WARNINGS

    WARNING: If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

  • INACTIVE INGREDIENT

  • PURPOSE

    Natural relief for muscle spasm, tension, and stress

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance.

  • ACTIVE INGREDIENT

    Each Tablet Contains: 6 parts Valerian Root (Quad Strength) 1X, 3 parts Passiflora (Quad Strength) 1X, 1 part Magnesium Carbonate 1X.

  • INDICATIONS & USAGE

    MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime.

    TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.

  • PRINCIPAL DISPLAY PANEL

    main panel

  • INGREDIENTS AND APPEARANCE
    FORMULA 303 
    valerian root, passiflora, magnesium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52301-303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (brown with dark brown speckles) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52301-303-25250 in 1 BOTTLE; Type 0: Not a Combination Product09/19/1990
    2NDC:52301-303-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/19/1990
    3NDC:52301-303-4545 in 1 BOTTLE; Type 0: Not a Combination Product09/19/1990
    4NDC:52301-303-2112 in 1 BAG; Type 0: Not a Combination Product06/23/2017
    5NDC:52301-303-6060 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2017
    6NDC:52301-303-30300 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2017
    7NDC:52301-303-12120 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/19/1990
    Labeler - Dee Cee Laboratories (034731893)
    Registrant - Dee Cee Laboratories (034731893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dee Cee Laboratories034731893manufacture(52301-303)