Label: SOMINEX- diphenhydramine hydrochloride tablet

  • 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 November 21, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine HCI 25 mg

    Purpose

    Nighttime sleep-aid

  • Use

    helps reduce difficulty falling asleep

  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic beverages • be careful when driving a motor vehicle or operating machinery

    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 breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor.

  • Other information

    • each tablet contains: calcium 10mg
    • store at room temperature 20°-25°C (68°-77°F)

  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C blue no.1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin.

  • Questions?

    1-866-255-5202 weekdays

  • Package Labeling:

    Sominex

  • INGREDIENTS AND APPEARANCE
    SOMINEX 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-169(NDC:63029-555)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-169-011 in 1 CARTON09/22/2016
    18 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33809/22/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-169) , repack(67751-169)