Label: CONSTIPATION- abies nig., aesculus hipp., aloe, alumina, bryonia, carbo veg., chelidonium majus, collinsonia, graphites, hydrastis, kali carb., lycopodium, mag. mur., mezereum, nux vom., podoph. pelt., rhamnus purshiana, sanicula, selenium, sepia, silicea, tabacum, veratrum alb., zinc. met., echinacea, iris versicolor, phytolacca, taraxacum pellet

  • 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 March 1, 2011

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  • INDICATIONS & USAGE SECTION

    Constipation  Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 15x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

  • QUESTIONS SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256 

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    CONSTIPATION  
    abies nig., aesculus hipp., aloe, alumina, bryonia, carbo veg., chelidonium majus, collinsonia, graphites, hydrastis, kali carb., lycopodium, mag. mur., mezereum, nux vom., podoph. pelt., rhamnus purshiana, sanicula, selenium, sepia, silicea, tabacum, veratrum alb., zinc. met., echinacea, iris versicolor, phytolacca, taraxacum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Picea Mariana Resin (UNII: 71AOV0W131) (Picea Mariana Resin - UNII:71AOV0W131) Picea Mariana Resin15 [hp_X]  in 1 g
    Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut15 [hp_X]  in 1 g
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe15 [hp_X]  in 1 g
    Aluminum Oxide (UNII: LMI26O6933) (Aluminum Oxide - UNII:LMI26O6933) Aluminum Oxide15 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 g
    Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal15 [hp_X]  in 1 g
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 g
    Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root15 [hp_X]  in 1 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 g
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal15 [hp_X]  in 1 g
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate15 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 g
    Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride15 [hp_X]  in 1 g
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 g
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum15 [hp_X]  in 1 g
    Frangula Purshiana Bark (UNII: 4VBP01X99F) (Frangula Purshiana Bark - UNII:4VBP01X99F) Frangula Purshiana Bark15 [hp_X]  in 1 g
    Sanicula Europaea Leaf (UNII: JYZ6110L9I) (Sanicula Europaea Leaf - UNII:JYZ6110L9I) Sanicula Europaea Leaf15 [hp_X]  in 1 g
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium15 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 g
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide15 [hp_X]  in 1 g
    Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [hp_X]  in 1 g
    Veratrum Album Root (UNII: QNS6W5US1Z) (Veratrum Album Root - UNII:QNS6W5US1Z) Veratrum Album Root15 [hp_X]  in 1 g
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 g
    Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root3 [hp_X]  in 1 g
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1705-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-1705-256.7 g in 1 BOTTLE, GLASS
    3NDC:55714-1705-07.08 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-1705)
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