Label: CRATAEGUS COMBINATION 9220- crataegus combination 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

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

View All Sections
  • ACTIVE INGREDIENTS

    Crataegus 1X
    Spigelia anthelmia 2X
    Kali carbonicum 3X
    Arnica montana 4X
    Cactus grandiflorus 4X
    Gelsemium sempervirens 4X
    Castoreum 6X
    Glonoinum 6X
    Ranunculus bulbosus 6X
    Sulphur 12X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of occasional insomnia, restlessness, or anxiousness.*

  • PURPOSE

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

  • WARNINGS

    In case of overdose, get medical help or contact a poison control center right away.

    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. 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

    40% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Crataegus Combination

    Homeopathic Remedy

    1 FL. OZ. (29.5 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    CRATAEGUS COMBINATION  9220
    crataegus combination liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-9220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER1 [hp_X]  in 29.5 mL
    SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE2 [hp_X]  in 29.5 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE3 [hp_X]  in 29.5 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE4 [hp_X]  in 29.5 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]  in 29.5 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 29.5 mL
    CASTOR FIBER SCENT GLAND SECRETION (UNII: 9X8XFD5ZQX) (CASTOR FIBER SCENT GLAND SECRETION - UNII:9X8XFD5ZQX) CASTOR FIBER SCENT GLAND SECRETION6 [hp_X]  in 29.5 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN6 [hp_X]  in 29.5 mL
    RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS WHOLE - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE6 [hp_X]  in 29.5 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 29.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-9220-129.5 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(63083-9220)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!