Label: MORNING SICKNESS AND NAUSEA PELLETS- chamomilla, hydrastis canadensis, iris versicolor, bismuthum metallicum, bryonia, cimicifuga racemosa, gossypium herbaceum, ipecacuanha, kreosotum, lycopodium clavatum, magnesia carbonica, nux vomica, pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber officinale. 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 September 8, 2022

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  • INDICATIONS & USAGE SECTION

    Formulated for associated symptoms such as dizziness, discomfort, indigestion, nausea, vomiting and loss of appetite.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Adults: On your first day of taking the remedy, take 3 pellets under the tongue every 30 minutes for 6 doses beginning at the onset of symptoms. If you feel that your symptoms are not improving, increase frequency to 3 pellets every 15 minutes. Once symptoms start improving, stop treatment.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Chamomilla 6x, Hydrastis 6x, Iris ver. 6x, Bismuth. met. 15x, Bryonia 15x, Cimicifuga 15x, Gossypium 15x, Ipecac. 15x, Kreosotum 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom. 15x, Pulsatilla 15x, Sepia 15x, Symphoricarpus 15x, Tabacum 15x, Zingiber 15x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as dizziness, discomfort, indigestion, nausea, vomiting and loss of appetite.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, Non-GMO, organic beet-derived sucrose (lactose-free) pellets.

  • QUESTIONS SECTION

    Distributed by Legendairy Milk - Question? 512.240.2655

    1007 S. Heatherwild Blvd., Unit 100

    Pflugerville, TX 78660

  • WARNINGS SECTION

    WARNINGS: 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.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    MORNING SICKNESS AND NAUSEA PELLETS 
    chamomilla, hydrastis canadensis, iris versicolor, bismuthum metallicum, bryonia, cimicifuga racemosa, gossypium herbaceum, ipecacuanha, kreosotum, lycopodium clavatum, magnesia carbonica, nux vomica, pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber officinale. pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82952-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 1 g
    BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH15 [hp_X]  in 1 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH15 [hp_X]  in 1 g
    GOSSYPIUM HERBACEUM ROOT BARK (UNII: VQN1631P4C) (GOSSYPIUM HERBACEUM ROOT BARK - UNII:VQN1631P4C) GOSSYPIUM HERBACEUM ROOT BARK15 [hp_X]  in 1 g
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 g
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE15 [hp_X]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE15 [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
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 g
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 g
    SYMPHORICARPOS ALBUS FRUIT (UNII: 873JZU3ASZ) (SYMPHORICARPOS ALBUS FRUIT - UNII:873JZU3ASZ) SYMPHORICARPOS ALBUS FRUIT15 [hp_X]  in 1 g
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF15 [hp_X]  in 1 g
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 g
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 g
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82952-0001-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/08/2022
    Labeler - Legendairy Milk (006228879)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(82952-0001)
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