Label: WELLNESS WITH CHERRY FLAVOR COUGH SYRUP- althaea officinalis, prunus virginiana, inula helenium syrup

  • 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 October 16, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients:

    • Althaea officinalis 1x
    • Prunus virginiana 1x
    • Inula helenium 3x
    • Marrubium vulgare 3x
    • Eucalyptus globulus 6x
    • Rumex crispus 6x
    • Sanguinaria canadensis 6x
    • Bryonia alba 12x
    • Causticum 12x
    • Nux vomica 12x
    • Phosphorus 12x
    • Pulsatilla nigricans 12x
  • PURPOSE

    • Homeopathic cough syrup for kids and teens
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
  • INDICATIONS & USAGE

    • For the temporary relief of coughs and congestion due to cold and flu.
    • Helps loosen mucus (expectorant) and clear bronchial congestion.
    • Soothes sore throat.
    •         For best Results:
      • Keep mouth free of food and strong tastes for 15 minutes before and after taking.
      • Hold liquid in mouth for 10-15 seconds before swallowing.
  • WARNINGS

    • In case of overdose get medical help or contact poison control center right away
    • A persistent cough may be a sign of a serious condition
    • If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician
    • Do not give this product for persistent or chronic cough associate with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician
    • As with any medicine, if you are pregnant, may become pregnant, or breasfeeding, seek the advice of a health care professional before using this product
  • DOSAGE & ADMINISTRATION

    • Adults and children 12 years of age and older:   
      • Take 2 teaspoons every 4 hours
      • Or as needed
    • Children 2 - 12 years of age:
      • Take 1 teaspoon every 4 hours  
      • Or as needed
    • Children under 2: Consult a physician for use
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    • Deionized water
    • Fructose
    • Natural Cherry flavor
    • Vanilla flavor
    • Natural color
    • Citric acid
    • Potassium Benzoate
    • Xanthan gum


  • PRINCIPAL DISPLAY PANEL

    image of label

    • bottle image jpeg
    • bottlelabel/.jpg
  • INGREDIENTS AND APPEARANCE
    WELLNESS WITH CHERRY FLAVOR  COUGH SYRUP
    althaea officinalis, prunus virginiana, inula helenium syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64471-185
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H) ALTHAEA OFFICINALIS ROOT1 [hp_X]  in 118 mL
    PRUNUS VIRGINIANA BARK (UNII: 477D3CRY10) (PRUNUS VIRGINIANA BARK - UNII:477D3CRY10) PRUNUS VIRGINIANA BARK1 [hp_X]  in 118 mL
    INULA HELENIUM ROOT (UNII: E55SMD6DA8) (INULA HELENIUM ROOT - UNII:E55SMD6DA8) INULA HELENIUM ROOT3 [hp_X]  in 118 mL
    MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z) MARRUBIUM VULGARE3 [hp_X]  in 118 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF6 [hp_X]  in 118 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 118 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]  in 118 mL
    BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE12 [hp_X]  in 118 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 118 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 118 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 118 mL
    Anemone nemorosa (UNII: 9IH59MK596) (Anemone nemorosa - UNII:9IH59MK596) Anemone nemorosa12 [hp_X]  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    CHERRY JUICE (UNII: 4XTQ10247Y)  
    VANILLA (UNII: Q74T35078H)  
    NATURAL RED 26 (UNII: P9ZT730WWS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64471-185-04118 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/16/2013
    Labeler - Source Naturals (969024228)
    Registrant - ABCO Laboratories, Inc. (029618279)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABCO Laboratories, Inc.029618279manufacture(64471-185)
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