Label: AWAKEN- daphne mezereum bark,sulfur,delphinium staphisagria seed,sepia officinalis juice,sodium chloride,phosphoric acid,dibasic potassium phosphate and thuja occidentalis leafy twig tablet

  • NDC Code(s): 54973-3333-1, 54973-3333-2
  • 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 November 28, 2022

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  • PURPOSE

    Natural relief of fatigue, drowsiness and irritability

  • Drug Facts

    Active Ingredients

    Purpose

    Kali Phosphoricum 6X HPUS

    difficulty waking, fatigue, anxiousness

    Mezereum 12X HPUS

    drowsiness

    Natrum Muriaticum 6X HPUS

    irritability, fatigue, drowsiness

    Phosphoricum Acidum 6X HPUS

    irritability, worry

    Sepia 30X HPUS

    drowsiness

    Staphysagria 30X HPUS

    irritability, drowsiness

    Sulphur 12X HPUS

    irritability, drowsiness

    Thuja Occidentalis 30X HPUS

    drowsiness, irritability

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

  • Uses

    Temporarily relieves the symptoms of difficulty waking, fatigue, anxiousness, drowsiness, irritability and worry.

  • WARNINGS

    As with any drug, ask 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 band is broken or missing.

    In case of emergency

    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.

  • Directions

    Adults & Children 12 years and over: dissolve 1-2 tablets under tongue 3 times per day.

  • INACTIVE INGREDIENT

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 50 TABLETS BOTTLE CARTON

    Non-habit forming

    NDC 54973-3333-1

    HOMEOPATHIC

    SINCE 1903

    Hyland's®

    Awaken

    Natural relief of fatigue,

    drowsiness and irritability*

    50 QUICK-DISSOLVING TABLETS

    ACTUAL SIZE 194 MG

    Carton

  • INGREDIENTS AND APPEARANCE
    AWAKEN 
    daphne mezereum bark,sulfur,delphinium staphisagria seed,sepia officinalis juice,sodium chloride,phosphoric acid,dibasic potassium phosphate and thuja occidentalis leafy twig tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID6 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) DIBASIC POTASSIUM PHOSPHATE6 [hp_X]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_X]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (Off-White to White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3333-11 in 1 CARTON12/01/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3333-24 in 1 POUCH; Type 0: Not a Combination Product12/01/201712/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2017
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3333) , pack(54973-3333) , label(54973-3333)
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