Label: UP AND UP CHILDRENS ALLERGY MEDICATION- 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 07/09

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

  • Active ingredient (in each 5 mL teaspoonful)

    Diphenhydramine HCl 12.5 mg

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  • Purpose

    Antihistamine

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  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itching of the nose or throat
    • runny nose
    • itchy, watery eyes
    • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose
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  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    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

    • avoid alcoholic drinks
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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.

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  • Directions

    • if needed, take every 4-6 hours
    • do not take more than 6 doses in 24 hours

    children under 4

    years of age
    do not use

    children 4 to under 6

    years of age
    do not use unless directed by a doctor

    children 6 to under

    12 years of age

    1 to 2 teaspoonfuls

    (12.5 mg to 25 mg)

    adults and children

    12 years of age

    and over

    2 to 4 teaspoonfuls

    (25 mg to 50 mg)
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  • Other information

    • each teaspoonful contains: sodium 15 mg
    • store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

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  • Questions?

    Call 1-800-910-6874

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  • Principal Display Panel

    Children’s Allergy Medication

    Diphenhydramine HCl

    Antihistamine

    Compare to active ingredient in Children's Benadryl® Allergy Liquid

    Alcohol-Free Liquid Medication

    Relieves Sneezing/Runny Nose/

    Itchy, Watery Eyes/Itchy Throat

    Cherry Flavor

    Age 6+ Years

    Children's Allergy Medication Carton

    Children's Allergy Medication Carton

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  • INGREDIENTS AND APPEARANCE
    UP AND UP CHILDRENS ALLERGY MEDICATION 
    diphenhydramine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-379
    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
    Product Characteristics
    Color RED (Bluish-Red) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-379-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/08/2009
    Labeler - Target Corporation (006961700)
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