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Qdryl Allergy (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
SOLUTION 1 BOTTLE, PLASTIC in 1 CARTON (0603-0823-54) > 118 mL in 1 BOTTLE, PLASTIC Label Information
SOLUTION 118 mL in 1 BOTTLE, PLASTIC (0603-0823-94) Label Information
SOLUTION 237 mL in 1 BOTTLE, PLASTIC (0603-0823-81) Label Information

Complete Qdryl Allergy Information

  • 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 years do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0823
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0823-54 1 in 1 CARTON 12/01/1997 10/31/2019
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:0603-0823-58 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/1997 10/31/2019
    3 NDC:0603-0823-81 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/1997 10/31/2019
    4 NDC:0603-0823-94 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/1997 10/31/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/01/1997 10/31/2019
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 ANALYSIS(0603-0823) , LABEL(0603-0823) , MANUFACTURE(0603-0823) , PACK(0603-0823)
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