Label: BACKACHE RELIEF- aconitum napellus, bryonia alba root, magnesium phosphate, dibasic trihydrate, bellis perennis, toxicodendron pubescens leaf and arnica montana 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 May 10, 2023

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  • PURPOSE

    Backache Relief

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Aconitum Napellus 6X HPUS

    backache pain

    Arnica Montana 6X HPUS

    backache pain

    Bellis Perennis 6X HPUS

    		backache pain

    Bryonia Alba 6X HPUS

    		backache pain

    Magnesia Phosphorica 6X HPUS

    		backache pain

    Rhus Toxicodendron 6X HPUS

    		backache pain

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

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves backache pain

  • Warnings

    Stop use and ask a doctor if

    ■ pain gets worse or lasts more than 7 days.
    ■ new symptoms occur.
    ■ redness or swelling is present

    If pregnant or breastfeeding

    Ask a health professional before use.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.

    Adults and children
    12 years and over

    At onset of symptoms, dissolve 2 tablets under tongue every

    15 minutes up to 4 doses. If symptoms persist, 2 tablets every

    4 hours until relieved.
    Children under
    12 years of age     		Ask a doctor before use.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

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

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • Principal Display Panel

    NDC 54973-4011-1

    100 TABLETS

    labelcarton

  • INGREDIENTS AND APPEARANCE
    BACKACHE RELIEF 
    aconitum napellus, bryonia alba root, magnesium phosphate, dibasic trihydrate, bellis perennis, toxicodendron pubescens leaf and arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (White to Off white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4011-11 in 1 CARTON03/30/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/30/2020
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4011) , pack(54973-4011) , label(54973-4011)
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