Label: QDRYL ALLERGY- diphenhydramine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 7, 2016

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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 USAfor Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Distributed by

    Atlantic Biologicals Corp

    Miami Fl 33179

    Rev. 3/15 R7
    8273205  0823

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    QDRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1823(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:17856-1823-110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product09/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/01/1997
    Labeler - ATLANTIC BIOLOGICALS CORP (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP047437707repack(17856-1823) , relabel(17856-1823)
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