FDA Label for Childrens Allergy Dye Free Wal Dryl

View Indications, Usage & Precautions

Childrens Allergy Dye Free Wal Dryl Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


Active Ingredient (In Each 5 Ml)



Diphenhydramine HCl USP 12.5 mg


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 throat or nose

Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use if the child has

  • •a breathing problem such as chronic bronchitis
  • •glaucoma

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers


Otc - When Using



When using this product

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

Otc - Keep Out Of Reach Of Children



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



  • •find right dose on chart below
  • •take every 4 to 6 hours, or as directed by a doctor
  • •do not take more than 6 doses in 24 hours
  • •mL = milliliter
  • Age (yr)

    Dose (mL)

    children under 2 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 mL to 10 mL

    Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device


Other Information



  • •each 5 mL contains: sodium 11 mg
  • •store at room temperature
  • •see bottom panel for lot number and expiration date
  • •protect from light
  • •contains very low sodium

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.


Questions?



1-866-467-2748


Principal Display Panel



Walgreens

NDC 0363-0710-08

Compare to Children’s Benadryl ® Dye-Free active ingredient††

children’s ALLERGY Dye-Free Wal-Dryl®

DIPHENHYDRAMINE HCl /ANTIHISTAMINE

12.5 mg/ 5 mL ORAL SOLUTION

DYE & SUGAR FREE

  • •For the relief of runny nose, itchy throat or nose, sneezing, & itchy, watery eyes

    AGES 6 -11 YEARS

  • BUBBLE GUM FLAVOR

    8 FL OZ (236 mL)

    Walgreens

    Pharmacist Recommended†

    Health expertise you rely on, quality you trust.

    †Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Johnson and Johnson owner of the registered trademark Children’s Benadryl® Dye–Free

    DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    IMPORTANT : KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD.,DEERFIELD,IL 60015

    Walgreens

    100% SATISFACTION GUARANTEED

    walgreens.com ©2017 Walgreen Co.


* Please review the disclaimer below.