Label: TMJ DROPS 2154- tmj drops liquid

  • 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Apis mellifica 1X
    Belladonna 12X
    Cartilage 12X
    Cicuta virosa 12X
    Kali carbonicum 12X
    Ligament 12X
    Muscle 12X
    Verbascum thapsus 12X, 30X
    Hepar sulphuris calcareum 30X
    Arnica montana 30X, 60X, 100X
    Spigelia anthelmia 60X, 100X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of minor jaw pain or noise, difficulty chewing, or occasional headache.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    TMJ Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    TMJ DROPS  2154
    tmj drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-2154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA1 [hp_X]  in 59 mL
    AMARYLLIS BELLADONNA WHOLE (UNII: 11B89M58UN) (AMARYLLIS BELLADONNA WHOLE - UNII:11B89M58UN) AMARYLLIS BELLADONNA WHOLE12 [hp_X]  in 59 mL
    BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) (UNII: 76TK29UQEZ) (BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) - UNII:76TK29UQEZ) BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE)12 [hp_X]  in 59 mL
    CICUTA VIROSA WHOLE (UNII: 3E698BL84C) (CICUTA VIROSA WHOLE - UNII:3E698BL84C) CICUTA VIROSA WHOLE12 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE12 [hp_X]  in 59 mL
    BOS TAURUS LIGAMENT (UNII: 0O005HD2J8) (BOS TAURUS LIGAMENT - UNII:0O005HD2J8) BOS TAURUS LIGAMENT12 [hp_X]  in 59 mL
    VERBASCUM THAPSUS WHOLE (UNII: C9TD27U172) (VERBASCUM THAPSUS WHOLE - UNII:C9TD27U172) VERBASCUM THAPSUS WHOLE12 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 59 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE30 [hp_X]  in 59 mL
    SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE60 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-2154-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-2154)
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