Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 35916-0438-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

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

View All Sections
  • Active ingredient

    (in each softgel)

    Diphenhydramine Hydrochloride USP 50 mg

  • PURPOSE

    Nighttime sleep-aid

  • Uses

    for relief of occasional sleeplessness

  • Do not use

    for 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
    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 drinks

  • Stop use and ask a doctor if

    sleeplessness persist 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.

  • Directions

    adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

  • Inactive ingredients

    Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

  • Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0438
    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
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorblue ((Transparent)) Scorescore with uneven pieces
    ShapeCAPSULE ((Oval)) Size13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0438-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/11/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/10/2024
    Labeler - Softgel Healthcare Pvt Ltd (675584180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0438)
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!