Label: SPORTS RECOVERY- apis mel., arnica, bellis, bryonia, calendula, chamomilla, cinchona, gelsemium, hamamelis, hypericum, lacticum acidum, ledum, phosphorus, rhus toxicodendron, ruta, sarcolacticum ac., staphysag., symphytum, echinacea, hydrastis liquid

  • 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 July 25, 2016

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    ​Warnings: Keep out of reach of children.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If ​pregnant or breast-feeding​, ask a doctor before use.

  • WARNINGS SECTION

    Warning:​Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding​, ask a doctor before use.

  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

    Questions? 1.800.448.7256

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

  • OTC - PURPOSE SECTION

    Formulated for work out recovery and for symptoms associated with injury, overexertion and emotional distress.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • INDICATIONS & USAGE SECTION

    Sports Recovery Formulated for workout recovery and for symptoms associated with injury, overexertion and emotional distress.

  • OTC - ACTIVE INGREDIENT SECTION

    Apis mel. 15x, Arnica 15x, Bellis 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Cinchona 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Lacticum acidum 15x, Ledum 15x, Phosphorus 15x, Rhus toxicodendron 15x, Ruta 15x, Sarcolacticum ac. 15x, Staphysag. 15x, Symphytum 15x, Echinacea 3x, Hydrastis 3x, Hypericum 3x, Symphytum 3x.

  • Package Label.Prinipal Display Panel

    Package Label

  • INGREDIENTS AND APPEARANCE
    SPORTS RECOVERY 
    apis mel., arnica, bellis, bryonia, calendula, chamomilla, cinchona, gelsemium, hamamelis, hypericum, lacticum acidum, ledum, phosphorus, rhus toxicodendron, ruta, sarcolacticum ac., staphysag., symphytum, echinacea, hydrastis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK15 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM15 [hp_X]  in 1 mL
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL-15 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP15 [hp_X]  in 1 mL
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-15 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED15 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT15 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1108-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/25/2016
    2NDC:55714-1108-259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/25/2016
    3NDC:55714-1108-015 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/25/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/25/2016
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-1108)
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