FORMULA 303 (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [DEE CEE LABORATORIES]

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FORMULA 303 (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [DEE CEE LABORATORIES]
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NDC 52301-303-12, 52301-303-21, 52301-303-25, 52301-303-30, 52301-303-45, 52301-303-60, 52301-303-90
Set ID 50d35250-36d4-24bf-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Dee Cee Laboratories
Generic Name
Product Class
Product Number
Application Number
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  • 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)
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