Label: MIRACET- abies nigra, aconitum napellus, arsenicum iodatum, avena sativa, ignatia amara, lung suis, nux vomica, plantago major, quebracho 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 August 1, 2013

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  • ACTIVE INGREDIENTS:

    Abies Nigra 10X, Aconitum Napellus 200C, Arsenicum Iodatum 200C, Avena Sativa 1X, Ignatia Amara 200C, Lung Suis 6X, Nux Vomica 10X, Plantago Major 3X, Quebracho 3X, Stricta Pulmonaria 200C, Tabacum 200C.

  • INDICATIONS:

    Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite.

  • WARNINGS:

    ​If you are pregnant or breast feeding,​ seek the advice of a doctor before use.

    ​Keep out of reach of children.​ 

    In case of overdose, get medical help or contact a Poison Control Center right away.

    ​Do Not use if imprinted tamper evident seal around neck of bottle is missing or broken.​

  • DIRECTIONS:

    ​Adults and Children over 12:​ Spray twice under the tongue 3 times per day.

    ​For Children under 12:​​ Consult a doctor prior to use.

  • INACTIVE INGREDIENTS:

    Alcohol 20% v/v, Purified water.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS:

    Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite.

  • QUESTIONS:

    Distributed By:

    Nutrology

    2049 North Lincoln Street

    Burbank, CA 91504

  • PACKAGE DISPLAY LABEL:

    MIRACET

    Nicotine Craving Relief

    HOMEOPATHIC

    1.0 fl. oz. (30 mL), 20% alcohol

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  • INGREDIENTS AND APPEARANCE
    MIRACET 
    abies nigra, aconitum napellus, arsenicum iodatum, avena sativa, ignatia amara, lung suis, nux vomica, plantago major, quebracho liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43695-0004
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131) PICEA MARIANA RESIN10 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS200 [hp_C]  in 1 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE200 [hp_C]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [hp_C]  in 1 mL
    SUS SCROFA LUNG (UNII: 7GL3G1COB3) (SUS SCROFA LUNG - UNII:7GL3G1COB3) SUS SCROFA LUNG6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
    ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190) ASPIDOSPERMA QUEBRACHO-BLANCO BARK3 [hp_X]  in 1 mL
    LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA200 [hp_C]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43695-0004-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2013
    Labeler - Pacific Naturals (184784283)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43695-0004) , api manufacture(43695-0004) , label(43695-0004) , pack(43695-0004)
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