Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride liquid

  • 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 30, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL or 2 tablespoons)

    Diphenhydramine HCl 50 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
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery

    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.

    Overdose warning

    Taking more than directed can cause serious health problems. 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) – see Overdose warning
    • use dose cup or tablespoon
    adults & children 12 yrs & overOne Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
  • Other information

    • each 30 mL dose (2 tablespoons) contains:
      sodium 21 mg
    • store at room temperature
    • protect from light. Does not meet USP <671>.
  • Inactive ingredients

    citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

  • Questions?

    1-732-249-6363

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    NDC 55315-003-12
    fred's®

    Warming
    Berry Flavor

    Nighttime
    Sleep-Aid

    Diphenhydramine HCl

    Non-Habit Forming
    Not for treating Cold
    or Flu

    Alcohol 10%

    See Warnings

    6 FL OZ (177 mL)

    fred's
    LAB TESTED
    Lab Tested for Quality
    Fred Tested for Satisfaction

    Compare To
    Vicks ZzzQuil®*

    Principal Display Panel - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sorbitol (UNII: 506T60A25R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Alcohol (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Glycerin (UNII: PDC6A3C0OX)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPURPLE (Dark) Score    
    ShapeSize
    FlavorCHERRY, BERRY, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-003-12177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33810/23/2013
    Labeler - fred's, Inc. (005866116)
    Registrant - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    NameAddressID/FEIBusiness Operations
    davAgen Pharmaceutical, LLC967545935MANUFACTURE(55315-003) , PACK(55315-003) , LABEL(55315-003) , ANALYSIS(55315-003)
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