QDRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [QUALITEST PHARMACEUTICALS]

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QDRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [QUALITEST PHARMACEUTICALS]
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NDC 0603-0823-54, 0603-0823-58, 0603-0823-81, 0603-0823-94
Set ID b808660f-83ef-4c24-b459-d709f0f64b68
Category HUMAN OTC DRUG LABEL
Packager Qualitest Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient (in each 5 mL = 1 tsp)

    Diphenhydramine HCl     12.5 mg

  • Purpose

    Antihistamine

  • Uses

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

    Ask a doctor or pharmacist before use if you are taking 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
  • PREGNANCY OR BREAST FEEDING

    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. (1-800-222-1222)

  • Directions

    • use an accurate measuring device to administer this medication
    • take every 4 to 6 hours
    children under 2 yearsdo not use

    children 2 to 5 years

    		ask a doctor

    children 6 years to under 12 years

    5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours

    adults and children 12 years and over

    		10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours
  • Other information

    • each tsp contains: sodium 5 mg
    • store at 15°- 30°C (59°- 86°F)
    • protect from freezing

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    citric acid, D&C red #33, FD&C red #40, flavor, glycerin, poloxamer 407, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 3/15 R7
    8273205  0823

  • PRINCIPAL DISPLAY PANEL

    This is an image of the carton for Q-dryl Allergy.
  • PRINCIPAL DISPLAY PANEL

    Q-dryl Allergy 4oz uncarton label
  • PRINCIPAL DISPLAY PANEL

    This is the label for Q-dryl 1 Pint (473mL)
  • INGREDIENTS AND APPEARANCE
    QDRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0823
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0603-0823-541 in 1 CARTON12/01/199710/31/2019
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0603-0823-58473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/199710/31/2019
    3NDC:0603-0823-81237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/199710/31/2019
    4NDC:0603-0823-94118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/199710/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/01/199710/31/2019
    Labeler - Qualitest Pharmaceuticals (011103059)
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