Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 57344-028-01, 57344-028-02, 57344-028-03, 57344-028-04, view more
    57344-028-05
  • Packager: AAA Pharmaceutical, Inc.
  • 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    relieves occasional sleeplessness

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  • Warnings

    Do not use

    • in 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

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product avoid alcoholic drinks

    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.

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  • Directions

    • adults and children 12 years of age and over: take two caplets (50 mg) at bedtime if needed, or as directed by a doctor
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  • Other information

    • each caplet contains: calcium 85 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • retain carton for complete product information
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 72 Caplet Bottle Carton

    RESTORE u

    NDC 57344-028-03

    COMPARE TO THE ACTIVE
    INGREDIENT IN NYTOL®
    QUICK CAPS

    Safe & Effective
    Fall Asleep Fast

    Nyt-time Sleep Caps

    NIGHTTIME SLEEP-AID
    Diphenhydramine HCl

    72 CAPLETS - 25 mg each

    Principal Display Panel - 72 Caplet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-028
    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
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code 93;XF;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-028-01 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:57344-028-02 4 in 1 CARTON
    2 8 in 1 BLISTER PACK
    3 NDC:57344-028-03 1 in 1 CARTON
    3 72 in 1 BOTTLE, PLASTIC
    4 NDC:57344-028-04 24 in 1 BOTTLE, PLASTIC
    5 NDC:57344-028-05 72 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 12/15/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-028)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-028)
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