Label: SOMNAPURE CLINICAL STRENGTH- diphenhydramine hydrochloride tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 9, 2015

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  • Drug Facts

    Active ingredient (in each caplet)

    Diphenhydramine HCl 50 mg

  • PURPOSE

    Purpose

    Nighttime sleep aid

  • INDICATIONS & USAGE

    Use for relief of occasional sleeplessness

  • WARNINGS

    Warnings

    Do not use

    • in children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid. 

    When using this product, avoid alcoholic drinks. 

    Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness. 

    If pregnant or breastfeeding, ask a health professional before use. 

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. 

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: 1 caplet (50 mg) at bedtime if needed, or as directed by a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, FD&C blue no. 2 lake, fractionated coconut oil, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, silicon dioxide, starch, stearic acid, talc titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-877-869-3304

  • PRINCIPAL DISPLAY PANEL

    Peak Life

    Somnapure®Clinical Strength

    Nighttime Sleep Aid / Diphenhydramine HCL

    • Fall Asleep Quickly 
    • Wake Up Energized
    • Non-Habit-Forming

    #1 Doctor-Recommended Ingredient

    30 Sleep Caplets

    One Caplet per Dose

    Distributed by Peak Life, LLC, 

    a subsidiary of NutraClick, LLC

    PeakLife.com / 1-877-869-3304

    Boston, MA 02108

    Outer Label

    Inner Box Label

  • INGREDIENTS AND APPEARANCE
    SOMNAPURE  CLINICAL STRENGTH
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69721-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code SPCS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69721-001-301 in 1 BOX
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/09/2015
    Labeler - NutraClick, LLC (831011809)
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