Label: PAIN RELIEF- dibasic potassium phosphate,hypericum perforatum,toxicodendron pubescens leaf,bryonia alba root and magnesium phosphate, dibasic trihydrate 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 8, 2023

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  • PURPOSE

    Pain Relief

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Bryonia Alba 6X HPUS

    minor joint pain, headache, muscle cramps

    Hypericum Perforatum 6X HPUS

    backache, headache, minor joint pain

    Kali Phosphoricum 6X HPUS

    pain in neck/shoulders, headache

    Magnesia Phosphorica 12X HPUS

    muscle pain, backache

    Rhus Toxicodendron 6X HPUS

    minor joint pain, headache, neck pain

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

    Pharmacopoeia of the United States.

  • 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.

  • Uses

    ■ Temporarily relieves: ■ minor joint pain ■ headache ■ muscle pain ■ backache ■ muscle cramps ■ pain in neck or shoulders

  • Principal Display Panel

    54973-4009-01

    100 Tablets

    carton 100 Tab

    label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    dibasic potassium phosphate,hypericum perforatum,toxicodendron pubescens leaf,bryonia alba root and magnesium phosphate, dibasic trihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) DIBASIC POTASSIUM PHOSPHATE6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4009-11 in 1 CARTON04/03/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2020
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4009) , pack(54973-4009) , label(54973-4009)
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