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

  • NDC Code(s): 41520-052-53, 41520-052-62
  • Packager: American Sales Company
  • 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 December 9, 2019

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

View All Sections
  • 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?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Vicks® ZzzQuil® Nighttime Sleep-Aid

    NIGHTTIME SLEEP AID

    Diphenhydramine HCl Softgels, 25mg

    Not For Treating Colds Or The Flu

    See Warnings

    Non-Habit Forming

    Actual Size

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    12 SOFTGELS

    052OF-nighttime-sleep-aid.jpg
  • INGREDIENTS AND APPEARANCE
    CAREONE NIGHTTIME SLEEP AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-052
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (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:41520-052-536 in 1 CARTON01/28/2014
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41520-052-6212 in 1 CARTON03/24/2014
    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 finalpart33801/28/2014
    Labeler - American Sales Company (809183973)
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!