Label: SLEEP- hyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic tablet

  • 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 14, 2022

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  • PURPOSE

    Relieves Occasional Sleeplessness Due to Nervousness or Worry

  • Drug Facts

    Active ingredientsPurpose

    Hyoscyamus Niger 6X HPUS

    (0.0000001% Alkaloids, calculated)

    		occasional sleeplessness

    Ignatia Amara 6X HPUS

    (0.0000017% Alkaloids, calculated)

    		anxiousness, worry
    Kali Phosphoricum 3X HPUSwakefulness, occasional sleeplessness, nervousness

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves symptoms of occasional sleeplessness due to:
    ■ anxiousness ■ worry
    ■ wakefulness ■ nervousness

  • Warnings

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

    Do not use more than directed.

    Stop use and consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of the reach of children.

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

  • Drug Facts (continued)

    Directions

    Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary.

    Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.

  • Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    HOMEOPATHIC

    NDC 54973-3206-1

    SINCE 1903

    Hyland's

    Sleep*

    NATURAL ACTIVE INGREDIENTS
    GENTLE ON YOU

    Relieves Occasional
    Sleeplessness Due
    to Nervousness
    or Worry

    100 QUICK-DISSOLVING TABLETS

    * SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

    NATURAL RELIEF

    Carton

  • INGREDIENTS AND APPEARANCE
    SLEEP 
    hyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3206-11 in 1 CARTON11/05/2014
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/05/2014
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3206) , pack(54973-3206)
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