Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Diphenhydramine HCl 12.5 mg

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  • Purpose

    Antihistamine

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  • Uses

    temporarily relieves:

    runny nose, sneezing
    itchy, watery eyes due to hay fever or other
    upper respiratory allergies
    itching of the nose or throat

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  • Do Not Use

    to make a child sleepy
    if you are on a sodium-restricted diet
    with any other product containing diphenhydramine,
    including one applied topically.

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  • 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

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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

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  • When using this product

    marked drowsiness may occur
    sedatives and tranquilizers may increase
    drowsiness
    excitability may occur, especially in children

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  • Keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional
    assistance or contact a Poison Control Center
    immediately.

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  • Directions

    use only enclosed dosing cup designed for use with
    this product. Do not use any other dosing device.
    take every 4 to 6 hours
    do not exceed 6 doses in a 24-hour period

    age                                                           dose
    children 6 years to under 12 years      1 to 2 teaspoonfuls (12.5 mg to 25 mg)
    children 4 years to under 6 years        do not use unless directed by a doctor
    children under 4 years                          do not use

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  • Other information

    each teaspoon contains: sodium 6 mg
    store at controlled room temperature

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  • Inactive ingredients

    citric acid, flavors, glycerin, poloxamer 407, purified water, red 33, red 40,
    sodium benzoate, sodium chloride, sodium citrate, and sugar

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  • Warnings

    Do not use to make a child sleepy or with any

    other product with Diphenhydramine even one

    used on skin

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  • Principal Panel Display

    Rite Aid Pharmacy

    Compare to the active ingredients in

    Children’s Benadryl Allergy

    Children’s allergy relief

    Diphenhydramine HCI 12.5 mg

    antihistamine oral solution

    indoor and outdoor allergies

    Alcohol Free

    Cherry Flavored

    Dosage cup included

    For Relief of sneezing

    Runny nose, itchy,

    Watery eyes, itchy throat

    6 years and older

    4 FL OZ (118 mL)

    image of label

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    benadryl liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0025
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    Glycerin  
    Poloxamer 407  
    Water  
    Sodium Benzoate  
    Sodium Chloride  
    Sodium Citrate  
    Sucrose  
    D&C RED NO. 33  
    FD&C RED NO. 40  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0025-4 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/18/2013
    Labeler - Rite Aid (014578892)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture(11822-0025), analysis(11822-0025)
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