QDRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC]

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QDRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC]
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NDC 68788-9095-1
Set ID 7169248d-ee02-45bd-b689-14bcbb078df6
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals, Inc
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 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

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL

    Q dryl Diphenhydramine Hydrochloride Allerg
  • INGREDIENTS AND APPEARANCE
    QDRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9095(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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-9095-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/1997
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Registrant - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9095)
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