Label: MENOPAUSE PLUS SLEEP- atropa belladonna, caulophyllum thalictroides root, black cohosh, nitroglycerin, strychnos ignatii seed, anemone pulsatilla, sepia officinalis juice, sulfur and lachesis muta venom kit

  • NDC Code(s): 54973-3355-1, 54973-3355-2, 54973-3356-1
  • Packager: Hyland's Inc.
  • 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 December 13, 2022

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  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Belladonna 12X HPUS

    hot flashes, night sweats

    Caulophyllum 12X HPUS

    irritability

    Cimicifuga Racemosa 12X HPUS

    hot flashes

    Glonoinum 12X HPUS

    occasional sleeplessness, restlessness

    Ignatia Amara 12X HPUS

    frequent waking, occasional sleeplessness, restlessness

    Lachesis 30X HPUS

    hot flashes

    Pulsatilla 12X HPUS

    hot flashes, night sweats

    Sepia Officinalis 12X HPUS

    irritability, hot flashes, night sweats

    Sulphur 12X HPUS

    hot flashes, night sweats

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    Temporarily relieves the symptoms of occasional sleeplessness, restlessness, frequent waking, irritability, hot flashes, and night sweats experienced during menopause.

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use: • more than directed.  • if you have a known allergy to any ingredient in this product.

    Consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

    Do not use if imprinted tamper-evident bottle sleeve is broken or missing.

    In case of emergency

    In case of emergency, contact a medical professional or Poison Control Center immediately. Doctor Wise by Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults: Take two tablets at onset of symptoms and repeat every four hours as needed.

  • Inactive ingredients

    Acacia Gum, Lactose

  • Questions or comments?

    (800) 624-9659

  • Principal Display Panel - Doctor Wise Menopause+ Sleep

    NDC 54973-3356-1

    DOCTOR

    WISE

    HOMEOPATHY

    MENOPAUSE+

    SLEEP

    Natural relief of occasional

    sleeplessness, frequent waking,

    hot flashes & night sweats*

    SOY

    FREE

    68 SUBLINGUAL TABLETS

    INCLUDES TWO 4-TABLETS SACHETS

    carton

  • INGREDIENTS AND APPEARANCE
    MENOPAUSE PLUS SLEEP 
    atropa belladonna, caulophyllum thalictroides root, black cohosh, nitroglycerin, strychnos ignatii seed, anemone pulsatilla, sepia officinalis juice, sulfur and lachesis muta venom kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3356
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3356-11 in 1 CARTON; Type 0: Not a Combination Product06/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 4 
    Part 21 BOTTLE, PLASTIC 60 
    Part 1 of 2
    MENOPAUSE PLUS SLEEP 
    nitroglycerin, strychnos ignatii seed, anemone pulsatilla, black cohosh, lachesis muta venom, sepia officinalis juice, sulfur, atropa belladonna and caulophyllum thalictroides root tablet
    Product Information
    Item Code (Source)NDC:54973-3355
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT12 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH12 [hp_X]
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (White to off-white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3355-24 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Part 2 of 2
    MENOPAUSE PLUS SLEEP 
    nitroglycerin, strychnos ignatii seed, anemone pulsatilla, black cohosh, lachesis muta venom, sepia officinalis juice, sulfur, atropa belladonna and caulophyllum thalictroides root tablet
    Product Information
    Item Code (Source)NDC:54973-3355
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT12 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH12 [hp_X]
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_X]
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (White to off-white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3355-160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3356) , pack(54973-3356) , label(54973-3356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merical, Inc118445308manufacture(54973-3356)
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