FDA.reportPublic FDA data

Childrens Allergy

Manufacturer
Select Brand Dist.
Effective date
2019-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:07:05

Label at a glance#

ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 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:

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

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 (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red #33, FD&C red #40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Allergy

Diphenhydramine HCI 12.5 mg

Antihistamine

RELIEVES

  • Sneezing
  • Runny nose
  • Itchy,Watery Eyes
  • Itchy Throat or Nose

*Compare to the active ingredient inChildren's Benadryl® Allergy

Cherry Flavor

Alcohol Free

For Ages 6 to 11 Years

FL OZ (mL)

Dosing Cup Included

*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:

SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

MADE IN THE USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Select Brand Children's Allergy
Select Brand Children's Allergy

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
15127-29215127-292-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCROSEC151H8M554IACT

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
bf833ee0-6201-4df3-93cd-c6224f443a56876b7cba-368b-49c9-9538-08ced23fc9072019-10-17WarningsExact identifier
spl id: bf833ee0-6201-4df3-93cd-c6224f443a56
spl set id: 876b7cba-368b-49c9-9538-08ced23fc907

Reported adverse events (FAERS/openFDA)#

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