Label: QUITTERS RELIEF HEADACHE- aconitum napellus,atropa belladonna,delphinium staphisagria seed,iris versicolor root and strychnos nux-vomica seed 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 headaches associated with smoking cessation

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Aconitum Napellus 6X HPUS

    headache

    Belladonna 6X HPUS (0.0000003% Alkaloids, calculated)

    headache

    Iris Versicolor 6X HPUS

    headache

    Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)

    headache

    Staphysagria 12X HPUS

    headache

    "HPUS" indicates that the active ingredients are in the official Homeopathic

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves headaches associated with smoking cessation

  • 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 54973-4005-1

    SINCE 1903

    Hyland's

    QUITTER’S RELIEF

    Headache*

    GENTLE RELIEF FOR SMOKING CESSATION SYMPTOMS

    No Acetaminophen, Ibuprofen

    or Caffeine

    100 QUICK-DISSOLVING

    TABLETS

    NATURAL

    RELIEF

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    QUITTERS RELIEF HEADACHE 
    aconitum napellus,atropa belladonna,delphinium staphisagria seed,iris versicolor root and strychnos nux-vomica seed tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [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:54973-4005-11 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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