Childrens Allergy by Harris Teeter, LLC Drug Facts

Drug Details [pdf]

CHILDRENS ALLERGY DYE FREE- diphenhydramine hydrochloride liquid
Harris Teeter, LLC

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Drug Facts

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 product 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 the 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 20-25ºC (68-77ºF). Do not refrigerate
Protect from light. Store in outer carton until contents are used

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, 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

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

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

CHILDRENS ALLERGY DYE FREE
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-293
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69256-293-04	1 in 1 BOX	05/28/2021	05/28/2025
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 Drug	M012	05/28/2021	05/28/2025

Labeler - Harris Teeter, LLC (048463103)

Revised: 12/2023

Document Id: f1a10c26-fa1f-40ee-b80f-afe1dfe4d236

Set id: 3e03e969-1aae-4dcd-b197-1b19cba00dc6

Version: 2

Effective Time: 20231212