Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 69452-427-10, 69452-427-17, 69452-427-79
  • Packager: BIONPHARMA INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2024

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

  • Active ingredient (in each capsule)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • For relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any product containing diphenhydramine, even one used on skin.
  • Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the 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 continuosly for more than 2 weeks, consult your doctor.

    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 Centre right away.

  • Directions

    • Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
    • swallow whole; do not crush, chew, or dissolve
  • Other information

    • store at 20 oC to 25 oC (68 oF to 77 oF)
    • avoid high humidity and excessive heat above 40 oC (104 oF).
    • protect from light
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-888-235-2466(Mon-Fri 9AM-5PM EST)

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

    This product is not manufactured or distributed by the owners of Unisom ® SleepGels ®.

    Manufactured for:

    Bionpharma Inc.

    Princeton, NJ 08540

    Made in India

    L0000778

    R0124

    Mfg. Lic. No.: TN00002123

    2620515

    Lot No.:

    Exp. Date:

  • 160's count

    Compare to the active ingredient in Unisom ®SleepGels ®

    NDC 69452-427-79

    a+ health

    maximum strength

    nighttime

    sleep-aid

    diphenhydramine HCl capsules USP, 50 mg

    fall asleep fast

    sleep soundly

    safe, non-habit

    forming

    one softgel per dose

    160 softgels**

    **liquid-filled capsules

    image001

    image002

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-427
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code B50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-427-79160 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
    2NDC:69452-427-1760 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
    3NDC:69452-427-1032 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/21/2024
    Labeler - BIONPHARMA INC. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(69452-427)