Label: DR. RECKEWEG R7 HEPAGALEN COMBINATION PRODUCT- carduus marianus 2x, chelidonium majus, radix 2x, cinchona 3x, cholesterinum 6x, colocynthis 6x, lycopodium clavatum 4x, nux vomica 4x 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 April 3, 2013

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  • ACTIVE INGREDIENT

    Active ingredients

    Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves digestive sluggishness, constipation, flatulence


  • INDICATIONS & USAGE


    Uses

    For the temporary relief of:


    • Digestive sluggishness
    • Constipation
    • Flatulence
  • WARNINGS

    Warnings

    Ask a doctor before useif you have

    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks.

    Ask a doctor before use

    • in children younger than 12 years.

    Stop use and ask a doctor if

    • rectal bleeding or failure to have a bowel movement after use of a laxative occurs because this may indicate a serious condition
    • symptoms persist over a period of more than 1 week.

    If pregnant or breastfeeding, ask a health care professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children ≥ 12 years 10-15 drops 1-3 times daily; acute cases: 10-15 drops 3-6 times daily in a little water or undiluted or as recommended.

    Not recommended for children under 12 years of age except under the advice of a health care professional.

  • OTHER SAFETY INFORMATION

    Other information
    Tamper resistant: Do not use if safety ring at base of cap is broken.

    Retain outer carton for full product instructions.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol, purified water.

  • QUESTIONS


    Questions?

    Call 1-800-361-7872 or email questions@reckeweg.com
  • PRINCIPAL DISPLAY PANEL

    image of carton label

    NDC# 53346-1307-5

    Dr. Reckeweg R7 Hepagalen

    Homeopathic preparation for the temporary relief of:

    • Digestive sluggishness
    • Constipation
    • Flatulence


    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R7 HEPAGALEN  COMBINATION PRODUCT
    carduus marianus 2x, chelidonium majus, radix 2x, cinchona 3x, cholesterinum 6x, colocynthis 6x, lycopodium clavatum 4x, nux vomica 4x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED2 [hp_X]  in 50 mL
    CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N) CHELIDONIUM MAJUS ROOT2 [hp_X]  in 50 mL
    CINCHONA BARK (UNII: 292E43P4I9) (CINCHONA BARK - UNII:292E43P4I9) CINCHONA BARK3 [hp_X]  in 50 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL6 [hp_X]  in 50 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 50 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 50 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED4 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1307-550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/1986
    Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO318602612manufacture(53346-1307)
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