Label: SOMINEX MAX- diphenhydramine hcl tablet

  • NDC Code(s): 63029-505-01, 63029-505-07, 63029-505-16
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each caplet)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    Helps to 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
    • drowsiness will occur

    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 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 1 caplet at bedtime if needed, or as directed by your doctor
  • Other information

    • store at room temperature 20º- 25ºC (68º-77ºF)
    • keep carton for future reference
  • 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 

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH FORMULA
    Sominex®
    NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
    16 TABLETS

    A label of a medicine bottle AI-generated content may be incorrect.

  • INGREDIENTS AND APPEARANCE
    SOMINEX MAX 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-505
    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, 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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-505-011 in 1 BOX06/01/201202/01/2019
    1NDC:63029-505-0716 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-505-161 in 1 BOX06/01/2012
    216 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/01/2012
    Labeler - Medtech Products Inc. (122715688)
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