Label: DR. RECKEWEG R5 GASTREU COMBINATION PRODUCT- anacardium orientale 6x, argentum nitricum 6x, arsenicum album 6x, belladonna 4x, carbo vegetabilis 8x, chamomilla 2x, chelidonium majus, radix 3x, lycopodium clavatum 5x, nux vomica 4x, scrophularia nodosa 1x 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 May 21, 2013

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  • ACTIVE INGREDIENT

    Active ingredients:

    Anacardium orientale 6X, Argentum nitricum 6X, Arsenicum album 6X, Belladonna 4X, Carbo vegetabilis 8X, Chamomilla 2X, Chelidonium majus, radix 3X, Lycopodium clavatum 5X, Nux vomica 4X, Scrophularia nodosa 1X, 1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves heartburn, sour stomach, acid indigestion


  • INDICATIONS & USAGE


    Uses

    For the temporary relief of:


    • Heartburn
    • Sour stomach
    • Acid indigestion

  • WARNINGS

    Warnings

    Ask a doctor before use

    • in children younger than 12 years.

    Stop use and ask a doctor if

    • symptoms persist over a period of more than 7 days
    • symptoms worsen or if new symptoms occur, because these could be signs of serious illness.  

    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 3 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 information.
  • 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# 53346-1305-5

    Dr. Reckeweg R5 Gastreu

    Homeopathic preparation for the temporary relief of:

    • Heartburn
    • Sour stomach
    • Acid indigestion

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R5 GASTREU  COMBINATION PRODUCT
    anacardium orientale 6x, argentum nitricum 6x, arsenicum album 6x, belladonna 4x, carbo vegetabilis 8x, chamomilla 2x, chelidonium majus, radix 3x, lycopodium clavatum 5x, nux vomica 4x, scrophularia nodosa 1x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEMECARPUS ANACARDIUM FRUIT (UNII: 7399B063X9) (SEMECARPUS ANACARDIUM FRUIT - UNII:7399B063X9) SEMECARPUS ANACARDIUM FRUIT6 [hp_X]  in 50 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_X]  in 50 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]  in 50 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 50 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL8 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]  in 50 mL
    CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N) CHELIDONIUM MAJUS ROOT3 [hp_X]  in 50 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE5 [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
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA1 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1305-550 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(53346-1305)
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