Label: NIGHTTIME SLEEP AID NON HABIT FORMING- diphenhydramine hydrochloride capsule, liquid filled 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/14

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

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

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

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • for children under 12 years of age
    • with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • heart disease
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep-aid.

    When using this product

    • drowsiness will occur
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • 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.

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  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    • swallow whole; do not crush, chew, or dissolve
    • adults & children 12 yrs & over
      • one dose= TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor
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  • Other information

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

    FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

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  • Questions or comments?

    Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

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  • Principal Display Panel

    Compare to the active ingredient in ZZZQUIL®*

    Nite Time Sleep- Aid

    Diphenhydramine HCl 25 mg

    Non Habit- Forming

    NOT FOR TREATING COLD OR FLU

    SEE WARNINGS

    Softgels**

    **Liquid-filled capsules

    Product of Canada

    *This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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  • Product Label

    Diphenhydramine 25mg

    Freds Nighttime Sleep Aid Softgels

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID  NON HABIT FORMING
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-225
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    WATER  
    FD&C RED NO. 40  
    SORBITOL  
    TITANIUM DIOXIDE  
    SORBITAN  
    Product Characteristics
    Color PURPLE Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code A41
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-225-12 1 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/11/2013
    Labeler - Freds Inc (005866116)
    Registrant - P and L Development of New York Corporation (800014821)
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