Label: TEETHING - COLIC- aconitum nap., apis mel., baptisia, belladonna, borax, bryonia, calc. carb., calc. phos., chamomilla, chelidonium majus, coffea cruda, collinsonia, colocynthis, kreosotum, mag.phos., nux vom., podoph. pelt., rheum, scutellarialateriflora, silicea, terebinthina, zingiber, valeriana 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

    Teething - Colic   Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

  • 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

    Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

  • 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
    TEETHING - COLIC  
    aconitum nap., apis mel., baptisia, belladonna, borax, bryonia, calc. carb., calc. phos., chamomilla, chelidonium majus, coffea cruda, collinsonia, colocynthis, kreosotum, mag.phos., nux vom., podoph. pelt., rheum, scutellarialateriflora, silicea, terebinthina, zingiber, valeriana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1709
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus10 [hp_X]  in 1 g
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera10 [hp_X]  in 1 g
    Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria10 [hp_X]  in 1 g
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna10 [hp_X]  in 1 g
    Sodium Borate (UNII: 91MBZ8H3QO) (Borate Ion - UNII:44OAE30D22) Sodium Borate10 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
    Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I) Oyster Shell Calcium Carbonate, Crude10 [hp_X]  in 1 g
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation10 [hp_X]  in 1 g
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita10 [hp_X]  in 1 g
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus10 [hp_X]  in 1 g
    Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean10 [hp_X]  in 1 g
    Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root10 [hp_X]  in 1 g
    Citrullus Colocynthis Fruit Pulp (UNII: 23H32AOH17) (Citrullus Colocynthis Fruit Pulp - UNII:23H32AOH17) Citrullus Colocynthis Fruit Pulp10 [hp_X]  in 1 g
    Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote10 [hp_X]  in 1 g
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate10 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum10 [hp_X]  in 1 g
    Rheum Officinale Root (UNII: A47JP5ZG9M) (Rheum Officinale Root - UNII:A47JP5ZG9M) Rheum Officinale Root10 [hp_X]  in 1 g
    Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC) Scutellaria Lateriflora10 [hp_X]  in 1 g
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide10 [hp_X]  in 1 g
    Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil10 [hp_X]  in 1 g
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger10 [hp_X]  in 1 g
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1709-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-1709-256.7 g in 1 BOTTLE, GLASS
    3NDC:55714-1709-07.08 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(55714-1709)
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