FDA.reportPublic FDA data

Childrens Allergy

Manufacturer
Harris Teeter, LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:18:35

Label at a glance#

ProductChildrens Allergy Dye Free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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

SPL UNCLASSIFIED SECTION

  • with any other product containing diphenhydramine, even one used on 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 the 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 8 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

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Children's

Dye-Free Allergy Liquid

12.5 mg/5 mL

Diphenhydramine HCI Oral Solution

ANTIHISTAMINE

Relieves:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of the Nose or Throat

For ages 6 to 11

Alcohol-Free

Dye-Free

Bubble Gum

Flavored

Dosing Cup included

FL OZ (mL)

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor 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.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HARRIS TEETER Children's Dye-Free Allergy Liquid Bubble Gum Flavor
HARRIS TEETER Children's Dye-Free Allergy Liquid Bubble Gum Flavor

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-29369256-293-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT

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
f1a10c26-fa1f-40ee-b80f-afe1dfe4d2363e03e969-1aae-4dcd-b197-1b19cba00dc62023-12-12WarningsExact identifier
spl id: f1a10c26-fa1f-40ee-b80f-afe1dfe4d236
spl set id: 3e03e969-1aae-4dcd-b197-1b19cba00dc6

Reported adverse events (FAERS/openFDA)#

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