Label: QUITTERS RELIEF IRRITABILITY- aconitum napellus whole, anamirta cocculus seed, arsenic trioxide, delphinium staphisagria seed, dibasic potassium phosphate, gelsemium sempervirens root, phosphorus, silver nitrate and sulfur tablet

  • 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 December 13, 2022

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  • PURPOSE

    Temporarily relieves symptoms of irritability associated with smoking cessation, including: anxiousness, restlessness, nervous, tension, occasional sleeplessness

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Aconitum Napellus 30X HPUS

    nervous tension

    Argentum Nitricum 30X HPUS

    nervous tension

    Arsenicum Album 30X HPUS

    nervousness, restlessness, anxiousness

    Cocculus Indicus 30X HPUS

    anxiousness, restlessness

    Gelsemium Sempervirens 30X HPUS

    irritability

    Ignatia Amara 30X HPUS

    (less than 0.0000000000017% Alkaloids, calculated)

    anxiousness, occasional sleeplessness

    Kali Phosphoricum 12X HPUS

    irritability

    Phosphorus 30X HPUS

    occasional sleeplessness

    Staphysagria 12X HPUS

    anxiousness and irritability associated with smoking cessation

    Sulphur 30X HPUS

    irritability

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves symptoms of irritability associated with smoking cessation, including:

    ■ anxiousness ■ restlessness ■ nervous tension ■ occasional sleeplessness

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use more than directed.

    Consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults ages 18

    years and over

    Dissolve 2 tablets under tongue every 15 minutes up to 4 doses,

    then every 4 hours until relieved.

  • Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    NDC 54973-4007-1

    SINCE 1903

    Hyland's

    QUITTER’S RELIEF

    Irritability*

    GENTLE RELIEF FOR SMOKING CESSATION SYMPTOMS

    Irritability, Anxiousness, Restlessness,

    Nervous Tension, Occasional Sleeplessness

    100 QUICK-DISSOLVING

    TABLETS

    NATURAL

    RELIEF

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    QUITTERS RELIEF IRRITABILITY 
    aconitum napellus whole, anamirta cocculus seed, arsenic trioxide, delphinium staphisagria seed, dibasic potassium phosphate, gelsemium sempervirens root, phosphorus, silver nitrate and sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE30 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE30 [hp_X]
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED30 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE12 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (Off White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4007-11 in 1 CARTON12/15/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/15/2020
    Labeler - Hyland's Inc. (008316655)
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