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Pill Identifier Information of Diphenhydramine Hydrochloride 25 MG Oral Tablet

Drug Information

Diphenhydramine Hydrochloride 25 MG Oral Tablet

Imprint: 25;052
Shape: C48345
Color: C48333
Ingredients: Diphenhydramine
Size: 11.00
Score: 1
Rxtty: SCD
Author: AAA Pharmaceutical, Inc.
Inactive Ingredients: SILICON DIOXIDE / CROSCARMELLOSE SODIUM / CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS / FD&C BLUE NO. 1 / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOLS / POLYSORBATE 80 / TITANIUM DIOXIDE>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness

  • Warnings

    Do not use
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age

    Ask a doctor before use if you have

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

    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.

  • Directions

    adults and children 12 years of age and overtake 2 caplets at bedtime if needed, or as directed by a doctor
    children under 12 years of agedo not use
  • Other information

    • each caplet contains: calcium 45 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • retain carton for complete product information
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

    RESTORE U

    NDC 57344-091-03

    †COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP ®

    Rest Simply

    actual size

    Diphehydramine HCl

    Nighttime Sleep-Aid

    Helps You Fall Asleep Fast, Non-Habit Forming, Use as Directed


    100 CAPLETS - 25 MG EACH

    image description

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-091
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 25;052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-091-031 in 1 CARTON10/05/2018
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01010/05/2018
    Labeler - AAA Pharmaceutical, Inc. (181192162)