FDA.reportPublic FDA data

Children Allergy Dye-Free Wal Dryl 20 single doses x 5mL ea

Manufacturer
Walgreens
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:49:14

Label at a glance#

ProductChildren Allergy Dye-Free Wal Dryl 20 single doses x 5mL ea
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and 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

Dosage and administration

do not take more than 6 doses in any 24 hour period give the recommended number of vials below following the instructions under How to Open and Use on the side panel empty each Single-Use Vial required, of all liquid when dosing this product does not contain directions or complete warnings for adult use. Dosing Chart Age Dose (mL) under 6 years old do not use unless directed by a doctor 6 – 11 years old 1 – 2 Sing...

Storage and handling

each Single-Use Vial contains 15mg of sodium store at 20-25ºC (68-77ºF) tamper evident: do not use if the top flap of the carton is open. Do not use if any vials are open or broken

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

• a breathing problem such as chronic bronchitis

• glaucoma

• a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24 hour period
  • give the recommended number of vials below following the instructions under How to Open and Use on the side panel
  • empty each Single-Use Vial required, of all liquid when dosing
  • this product does not contain directions or complete warnings for adult use.

Dosing Chart

Age Dose (mL)
under 6 years olddo not use unless directed by a doctor
6 – 11 years old 1 – 2 Single-Use Vials (5 mL Each) Every 4-6 hours. Do not exceed 12 Vials in 24 hours.

Other Information

STORAGE AND HANDLING SECTION

  • each Single-Use Vial contains 15mg of sodium
  • store at 20-25ºC (68-77ºF)
  • tamper evident: do not use if the top flap of the carton is open. Do not use if any vials are open or broken

Inactive Ingredient

INACTIVE INGREDIENT SECTION

citric acid, bubble gum flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

+1-800-925-4733

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-33940363-3394-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d42eb64f-ee6a-255d-e053-2995a90a7614aed315b4-b0a8-a321-e053-2a95a90ae8462021-12-28WarningsExact identifier
spl set id: aed315b4-b0a8-a321-e053-2a95a90ae846

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.