Label: SOMNAPURE CLINICAL STRENGTH- diphenhydramine hydrochloride tablet, coated

  • NDC Code(s): 69721-005-30
  • Packager: Force Factor Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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  • Drug Facts

    Active ingredient (in each caplet)

    Diphenhydramine HCl 50 mg

  • PURPOSE

    Purpose

    Nighttime sleep aid

  • INDICATIONS & USAGE

    Use 

    helps to reduce difficulty in falling asleep

  • 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 or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product, avoid alcoholic beverages. 

    Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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 (1-800-222-1222)  right away. 

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
    • Children under 12 years: do not use.
  • OTHER SAFETY INFORMATION

    Other information 

    • each caplet contains: calcium 50 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number.
    • protect from moisture
  • INACTIVE INGREDIENT

    Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium 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

    Force Factor Somnapure

    Clinical Strength

    Nighttime Sleep Aid / Diphenhydramine HCl

    #1 Doctor-Recommended Ingredient

    Fall Asleep Quickly
    Wake Up Energized
    Non-Habit-Forming

    30 Caplets

    One Caplet per Dose

    label

    box

  • INGREDIENTS AND APPEARANCE
    SOMNAPURE  CLINICAL STRENGTH
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69721-005
    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 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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:69721-005-301 in 1 CARTON03/20/2018
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/20/2018
    Labeler - Force Factor Brands LLC (831011809)
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