FDA.reportPublic FDA data

Childrens Allergy

Manufacturer
Dolgencorp, LLC | Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:57

Label at a glance#

ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 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

find right dose on chart below mL = milliliter  take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours 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 specifically designed for use with this product. Do not use any other dosing device.

Storage and handling

each 5 mL contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient [in each 5 mL]

Spl Unclassified Section

Diphenhydramine HCl, USP 12.5 mg

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

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

Ask a doctor before use if the 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

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

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 specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

1-888-309-9030

 DISTRIBUTED BY
DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG® health
Compare to the active ingredient of Children's Benadryl® Allergy Liquid*
For Ages 6 to 11 Years
Children’s
Allergy
Diphenhydramine Hydrochloride 12.5 mg/5 mL Oral Solution
Antihistamine

  • Alcohol free

Relieves runny nose, sneezing, itchy throat & watery eyes
Cherry Flavor
8 FL OZ (236 mL)
12.5 mg per 5 mL
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-99155910-991-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
CHERRYBUC5I9595WIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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
57675090-1176-4907-9794-2f2161bbe7c9cc160711-eeae-45d9-8cdf-1cbaeb0519832020-11-27WarningsExact identifier
spl id: 57675090-1176-4907-9794-2f2161bbe7c9
spl set id: cc160711-eeae-45d9-8cdf-1cbaeb051983

Reported adverse events (FAERS/openFDA)#

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