Label: PREMIER VALUE SLEEP-AID- diphenhydramine hcl capsule

  • 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 May 30, 2013

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  • ACTIVE INGREDIENT(S)

    Diphenhydramine HCl 50 mg

  • PURPOSE

    Nighttime sleep- aid

  • USE(S)

    • helps to reduce difficulty falling asleep
  • WARNINGS

    Do not give to children under 12 years of age.

  • DO NOT USE

    • With other products containing diphenhydramine, even one used on skin.
  • ASK A DOCTOR BEFORE USE IF

    • emphysema
    • chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the prostate gland
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    Sedatives or tranquilizers

  • WHEN USING THIS PRODUCT

    Avoid alcoholic beverages

  • STOP USE AND ASK DOCTOR IF

    •  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • PREGNANCY/BREASTFEEDING

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DIRECTIONS

    • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
  • STORAGE

    • Store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
  • INACTIVE INGREDIENTS

    Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

  • PRINCIPAL DISPLAY PANEL

    Carton Label PDP

    NDC # 68016-302-32

    Sleep-Aid
    DIPHENHYDRAMINE HCL 50 mg

    GET TO SLEEP FAST
    SLEEP SOUNDLY
    WAKE REFRESHED

    32 Softgels


    diphen-carton-lab





    Bottle Label PDP

    NDC # 68016-302-32

    Sleep-Aid
    DIPHENHYDRAMINE HCL 50 mg

    GET TO SLEEP FAST
    SLEEP SOUNDLY
    WAKE REFRESHED

    32 Softgels


    diphen-bott-label

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE SLEEP-AID 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-302
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code 22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-302-321 in 1 CARTON
    132 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/31/2013
    Labeler - Chain Drug Consortium LLC (101668460)
    Registrant - Chain Drug Consortium LLC (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(68016-302)
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