Label: PAINAZOL (actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia (alba), calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, ledum palustre, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla- pratensis, rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, sulphur, zincum metallicum 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 November 8, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE HPUS INGREDIENTS:

    Actaea Spicata 10X, 20X, 30X, 200C, Aesculus Hippocastanum 10X, 20X, 30X, 200C, Arnica Montana 10X, 20X, 30X, 200C, Bellis Perennis 10X, 20X, 30X, 200C, Bryonia (Alba) 10X, 20X, 30X, 200C, Calcarea Carbonica 10X, 20X, 30X, 200C, Calcarea Fluorica 10X, 20X, 30X, 200C, Causticum 10X, 20X, 30X, 200C, Cimicifuga Racemosa 10X, 20X, 30X, 200C, Formicum Acidum 10X, 20X, 30X, 200C, Hypericum Perforatum 10X, 20X, 30X, 200C, Ledum Palustre 10X, 20X, 30X, 200C, Lithium Carbonicum 10X, 20X, 30X, 200C, Magnesia Phosphorica 10X, 20X, 30X, 200C, Phosphorus 10X, 20X, 30X, 200C, Phytolacca Decandra 10X, 20X, 30X, 200C, Pulsatilla (Pratensis) 10X, 20X, 30X, 200C, Rhododendron Chrysanthum 10X, 20X, 30X, 200C, Rhus Tox 10X, 20X, 30X, 200C, Ruta Graveolens 10X, 20X, 30X, 200C, Salicylicum Acidum 10X, 20X, 30X, 200C, Sepia 10X, 20X, 30X, 200C, Sulphur 10X, 20X, 30X, 200C, Zincum Metallicum 10X, 20X, 30X, 200C.

  • INDICATIONS FOR USE:

    For the temporary relief of symptoms such as:

    • pain

    • burning

    • weakness

    • sensitivity

    • tingling

    • numbness

    Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

  • WARNINGS:

    Stop use and as a doctor if symptoms persist or worsen.

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

  • STORAGE & HANDLING:

    Do not store next to electrical devices or appliances.

    Keep lid tightly closed & store in a cool, dry place.

  • DIRECTIONS:

    Dissolve under tongue.

    30-50lb (13.6 kg-22.6kg): 1/2 tablet twice daily.

    50lb+ (22.6kg): 1 tablet twice daily.

  • INDICATIONS FOR USE:

    For the temporary relief of symptoms such as:

    • pain

    • burning

    • weakness

    • sensitivity

    • tingling

    • numbness

    Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

  • INACTIVE INGREDIENTS:

    Advantol 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

  • QUESTIONS:

    Dist. by: HelloLife, Inc.

    4635 40th St SE

    Grand Rapids, MI 49512

    Call us toll-free at:

    1-800-875-0850 or visit us on

    the web at www.hellolife.net

  • PACKAGE LABEL DISPLAY:

    NDC 49726-046-60
    PAINAZOL
    TABLETS
    Natural Relief for
    Respiratory Symptoms
    Homeopathic (OTC) Medicine
    60 Quick-dissolving Tablets

    Painazol

  • INGREDIENTS AND APPEARANCE
    PAINAZOL 
    actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia (alba), calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, ledum palustre, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla (pratensis), rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, sulphur, zincum metallicum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT10 [hp_X]
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT10 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]
    FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID10 [hp_X]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG10 [hp_X]
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE10 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS10 [hp_X]
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF10 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP10 [hp_X]
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 [hp_X]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    COPOVIDONE (UNII: D9C330MD8B)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49726-046-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/28/2019
    Labeler - HelloLife, Inc. (065619378)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(49726-046) , api manufacture(49726-046) , label(49726-046) , pack(49726-046)