Label: DR. RECKEWEG R14 QUIETA COMBINATION PRODUCT- ammonium bromatum 3x, avena sativa 1x, chamomilla 4x, coffea cruda 4x, eschscholtzia californica 2x, humulus lupulus 2x, ignatia amara 6x, passiflora incarnata 2x, valeriana officinalis 1x, zincum valerianicum 6x liquid

  • Category: HUMAN OTC DRUG LABEL

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 15, 2013

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  • ACTIVE INGREDIENT

    Active ingredients

    Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X,

    Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves sleeplessness caused by worry, overwork, stress and tension

  • INDICATIONS & USAGE


    Uses

    For the temporary relief of:


    • Sleeplessness caused by worry, overwork, stress and tension
  • WARNINGS

    Warnings

    Ask a doctor before use in children younger than 12 years.

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks
    • sleeplessness may be a symptom of serious underlying medical 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 5-10 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# 53346-1314-5

    Dr. Reckeweg R14 Quieta

    Homeopathic preparation for the temporary relief of:

    • Sleeplessness caused by worry, overwork, stress and tension

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R14 QUIETA  COMBINATION PRODUCT
    ammonium bromatum 3x, avena sativa 1x, chamomilla 4x, coffea cruda 4x, eschscholtzia californica 2x, humulus lupulus 2x, ignatia amara 6x, passiflora incarnata 2x, valeriana officinalis 1x, zincum valerianicum 6x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE3 [hp_X]  in 50 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_X]  in 50 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_X]  in 50 mL
    ESCHSCHOLZIA CALIFORNICA FLOWERING TOP (UNII: 023XWA119J) (ESCHSCHOLZIA CALIFORNICA FLOWERING TOP - UNII:023XWA119J) ESCHSCHOLZIA CALIFORNICA FLOWERING TOP2 [hp_X]  in 50 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 50 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]  in 50 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]  in 50 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]  in 50 mL
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE6 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1314-550 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(53346-1314)
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