Label: SOMINEX- diphenhydramine hcl tablet

  • NDC Code(s): 63029-555-01, 63029-555-16, 63029-555-32
  • Packager: Medtech Products Inc.
  • 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 January 30, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    helps reduce difficultly 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 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 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 10 mg
    • store at 20º- 25ºC (68º-77ºF)
  • Inactive ingredients

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

  • Questions?

    1-866-255-5202 weekdays or visit www.sominex.com

  • PRINCIPAL DISPLAY PANEL

    ORIGINAL FORMULA

    Sominex®

    NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

    16 TABLETS

    PRINCIPAL DISPLAY PANEL
ORIGINAL FORMULA
Sominex®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
16 TABLETS

    ORIGINAL FORMULA

    Sominex®

    NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 

    32 TABLETS

    ORIGINAL FORMULA
Sominex®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 
32 TABLETS

    ORIGINAL FORMULA

    Sominex®

    NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 

    72 TABLETS

    ORIGINAL FORMULA
Sominex®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 
72 TABLETS

  • INGREDIENTS AND APPEARANCE
    SOMINEX 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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:63029-555-011 in 1 BOX06/01/2012
    172 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-555-321 in 1 BOX06/01/2012
    232 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63029-555-161 in 1 BOX06/01/2012
    316 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33806/01/2012
    Labeler - Medtech Products Inc. (122715688)