CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]

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CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]
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NDC 59779-044-10
Set ID ec5a5404-dc36-4e94-b6d9-c2ef38a2a07c
Category HUMAN OTC DRUG LABEL
Packager CVS PHARMACY, INC.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)*

    Diphenhydramine HCl 12.5 mg

    *5 mL = one pre-filled spoon

  • 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
  • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a sodium-restricted diet

    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

    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

    • refer to chart below
    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    Children under 2 years of agedo not use
    Children 2 to 5 years of agedo not use unless directed by a doctor
    Children 6 to 11 years of age1 to 2 pre-filled spoons (12.5 mg to 25 mg)
    Adults and children 12 years of age and over2 to 4 pre-filled spoons (25 mg to 50 mg)
  • Other information

    • each pre-filled spoon contains: sodium 14 mg
    • store between 20-25°C (68-77°F).
    • Protect from light. Store in outer carton until contents used.
    • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

    Call 877-545-3635

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Benadryl® Allergy Perfect Measure

  • PRINCIPAL DISPLAY PANEL

    NDC 59779-044-10

    CVS Pharmacy Pre-measured spoon
    Children's
    ALLERGY LIQUID MEDICATION    ®


    Diphenhydramine HCI
    Oral Solution Antihistamine

    Relieves:

    • Sneezing
    • Runny Nose
    • Itchy, watery eyes
    • Itchy Throat

    Cherry Flavored

    Alcohol Free

    10 PRE-FILLED SINGLE USE SPOONS**
    0.17 FL OZ (5 mL) EACH

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY PRE-MEASURED SPOON CHILDRENS  ALLERGY MEDICATION
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-044
    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)  
    ammonium glycyrrhizate (UNII: 3VRD35U26C)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-044-1010 in 1 CARTON
    15 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/25/2011
    Labeler - CVS PHARMACY, INC. (062312574)
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