Label: HEDERA COMP.- hedera helix flowering twig, thyme, marrubium vulgare, and glycyrrhiza glabra solution

  • 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 13, 2021

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  • Use

    For the temporary relief of cough and sinus congestion

  • Directions

    Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

  • Ingredients

    Hedera helix Ø (N) 40%, Thymus vulgaris Ø (N) 35%, Marrubium vulgare Ø (N) 15%, Glycyrrhiza glabra Ø (N) 10%

  • INACTIVE INGREDIENT

    Alcohol: 65

  • TAMPER-EVIDENT

    Do not use if tamper evident strip is broken from base of cap.

  • WARNING

    Ask a doctor if you are pregnant or nursing.

    Keep away from children. In case of overdose, call a medical professional.

  • PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

    CERES®
    Homeopathic Medicine

    Hedera comp.

    Use: For the temporary relief of cough and
    sinus congestion

    Directions : Adults and children above 12 years: 2-5
    drops 1-3 times daily in pure water before meals. Consult
    a physician for use in children under 12 years of age.

    0.67 fl. oz. (20ml)
    Lot#: 1234567A
    EXP: 99.9999

    Principal Display Panel - 20 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    HEDERA COMP. 
    hedera helix flowering twig, thyme, marrubium vulgare, and glycyrrhiza glabra solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13838-1432
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM) HEDERA HELIX FLOWERING TWIG0.4 [hp_X]  in 1 mL
    THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N) THYME0.35 [hp_X]  in 1 mL
    MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z) MARRUBIUM VULGARE0.15 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA0.1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13838-1432-120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/01/2005
    Labeler - Phytodyne Inc. (164980927)
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