Label: CORRECT DOSE- diphenhydramine hydrochloride liquid

  • 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 May 25, 2011

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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 sealed pouches. Do not use if individual pouches are 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?

    1-877-545-3635

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

  • PRINCIPAL DISPLAY PANEL

    NDC 76103-004-10

    Correct Dose
    Children's
    Allergy Relief    ®


    Diphenhydramine HCI
    Oral Solution Antihistamine

    Correct Dose HELPS RELIEVE

    • Sneezing
    • Runny Nose
    • Itchy Eyes & Throat
    • Watery Eyes

    CHERRY FLAVOR

    Alcohol Free

    10 PRE-FILLED SINGLE USE SPOONS**
    0.17 FL OZ (5 mL) EACH
    **12.5 mg Diphenhydramine HCl each

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CORRECT DOSE   CHILDRENS ALLERGY RELIEF
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76103-004
    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)  
    glycyrrhizin, ammoniated (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:76103-004-1010 in 1 CARTON
    15 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/15/2011
    Labeler - BFS Pharma, Inc. (967271458)
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