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NDC 00363-0293-04 Dye Free Wal Dryl Allergy 12.5 mg/5mL Details

Dye Free Wal Dryl Allergy 12.5 mg/5mL

Dye Free Wal Dryl Allergy is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-0293-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00363-0293
Product ID	0363-0293_e4dd456f-266e-48ac-9c85-337914fae153
Associated GPIs	60300020100110
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dye Free Wal Dryl Allergy
Proprietary Name Suffix	childrens
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/5mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Walgreens
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0293-04 (00363029304)

Pricing Information	N/A
NDC Package Code	0363-0293-04
Billing NDC	00363029304
Package	1 BOTTLE, PLASTIC in 1 BOX (0363-0293-04) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2015-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 53e6f72d-15a4-4efe-8b1f-5753fed53df8 Details

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use

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

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than 6 doses in 24 hours
take every 4 to 6 hours, or as directed by a doctor
measure only with dosing cup provided. Do not use any other dosing device.
mL = milliliter
keep dosing cup with product
find the right dose on the chart below

age (yr)	dose (mL)
children 6 to 11 years	5 mL to 10 mL
children 2 to 5 years	do not use unless directed by a doctor
children under 2 years	do not use

Other information

each 5 mL contains: sodium 8 mg
store between 20-25°C (68-77°F). Do not refrigerate.
Protect from light. Store in outer carton until contents are used.

Inactive ingredients

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy††

Children's

Allergy

DIPHENHYDRAMINE HCI 12.5 mg /

5 mL ANTIHISTAMINE

Dye Free 4-6 Hour Relief

Alcohol Free

Relieves itchy or runny nose, sneezing, itchy throat & itchy, watery eyes

AGES

6-11 YEARS

Bubble Gum

DOSAGE CUP PROVIDED

FL OZ (mL)

††This product is not manufactured or distributed by McNeil Consumer Healthcare distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

WALGREENS Children's Allergy Relief Bubble Gum Flavor

INGREDIENTS AND APPEARANCE

DYE FREE WAL DRYL ALLERGY CHILDRENS

diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0293
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0293-04	1 in 1 BOX	03/31/2015
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/31/2015

Labeler - Walgreens (008965063)

Revised: 3/2022

Document Id: e4dd456f-266e-48ac-9c85-337914fae153

Set id: 53e6f72d-15a4-4efe-8b1f-5753fed53df8

Version: 6

Effective Time: 20220303