Label: NIGHTTIME SLEEP AID- diphenhydramine hcl 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 February 23, 2016

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

View All Sections
  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    provides relief of occasional sleeplessness

  • Warnings

    Do not use

    • with any other products containing diphenhydramine, even one used on skin

    • in children under 12 years of age

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operating a 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • do not take more than directed
    • adults and children 12 years of age and over - take 2 tablets at bedtime if needed or as directed by a doctor
    • children under 12 years of age: do not use
  • Other Information

    • each caplet contains; calcium 25 mg

    • store at controlled room temperature 15°-30°C (59°-86°F)

    • avoid excessive heat and humidity

  • Inactive Ingredients

    Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

  • Questions or comments?

    Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    image 25

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-014
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code EC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-014-2525 in 1 BOX
    14 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-014-5050 in 1 BOX
    24 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-014-022 in 1 BOX
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/04/2016
    Labeler - We Care Distributor Inc (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(70005-014)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!