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 March 20, 2018

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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 

    • each caplet contains: calcium 50 mg
    • store at 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesiu stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

  • QUESTIONS

    Questions of comments?  Call 1-855-606-6507

  • PRINCIPAL DISPLAY PANEL

    Peak Life Somnapure 

    Clinical Strength 

    Nighttime Sleep Aid / Diphenhydramine HCl 

    #1 Doctor-Recommended Ingredient

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

    30 Sleep Caplets 

    One Caplet per Dose

    LNK Carton

    LNK Carton

  • INGREDIENTS AND APPEARANCE
    SOMNAPURE  CLINICAL STRENGTH
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69721-003
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 44687
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69721-003-301 in 1 BOX03/20/2018
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33803/20/2018
    Labeler - NutraClick, LLC (831011809)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(69721-003)
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