Label: EQUALINE NIGHT TIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 41163-119-53, 41163-119-62
  • Packager: United Natural Foods, Inc. dba UNFI
  • 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 July 24, 2023

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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    •
    for the 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 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
    •
    difficulty in urination due to an 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

    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 right away (1-800-222-1222).

  • Directions

    •
    take only one dose per day (24 hours)
     
    adults & children 12 yrs & over

    2 softgels at bedtime if needed or as directed by a doctor
     
    children under 12 yrs

    do not use

    Other information

    •
    store at 20-25°C (68-77°F)
    •
    avoid excessive heat above 40°C (104°F)
    •
    protect from light
  • Inactive ingredients

    edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

    Questions or comments?

    1-877-932-7948

  • Package/Label Principal Display Panel

    compare to Vicks® ZzzQuil® active ingredient

    nighttime sleep-aid

    diphenhydramine HCl 25mg softgels

    doctor recommended #1 sleep-aid active ingredient

    non-habit forming

    NOT FOR TREATING COLD OR FLU

    SEE WARNINGS

    12 softgels

    actual size

    nighttime-sleep-aid-image
  • INGREDIENTS AND APPEARANCE
    EQUALINE NIGHT TIME SLEEP AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-119
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-119-536 in 1 CARTON03/07/2014
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41163-119-6212 in 1 CARTON03/07/201409/30/2021
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33803/07/2014
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
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