Home > Pill Identifier > Diphenhydramine Hydrochloride 25 MG Oral Capsule

Pill Identifier Information of Diphenhydramine Hydrochloride 25 MG Oral Capsule

Drug Information

Diphenhydramine Hydrochloride 25 MG Oral Capsule

Imprint: PC4
Shape: C48336
Color: C48330
Ingredients: Diphenhydramine
Size: 15.00
Score: 1
Rxtty: SCD
Author: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Inactive Ingredients: GELATIN / GLYCERIN / POLYETHYLENE GLYCOLS / WATER / SORBITOL>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

  • Warnings

    Do not use
    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

    When using this product
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over

       take 1 to 2 softgels

    children 6 to under 12 years of age

       take 1 softgel

    children under 6 years

       do not use this product in children under 6 years of age

  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from heat, humidity, and light
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

    manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
    Wuhan, Hubei
    430206, China

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg

    Quantity : 20000 Capsules
    NDC. No : 53345-007-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-007
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Coloryellow (clear) Scoreno score
    ShapeCAPSULE (OBLONG) Size15mm
    FlavorImprint Code PC4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-007-011 in 1 BOX09/15/2013
    120000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287manufacture(53345-007)
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