CHILDRENS DYE FREE ALLERGY- diphenhydramine hydrochloride liquid
P & L Development, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 drug 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 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 chart below

Age (yr)	Dose (mL)
children 6 to 11 years	5mL 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°-25°C (68°-77°F). Do not refrigerate.
protect from light. Store in outer carton until contents are used

Inactive ingredients

anhydrous citric acid,carboxymethyl cellulose sodium, flavor, 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 active ingredient in Children's Benadryl® Allergy*

Children's

dye-free

allergy

Diphenhydramine HCl 12.5 mg

Antihistamine

relieves:

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

For Ages 6 to 11

alcohol free

dye-free

bubblegum Flavor

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

Readyincase Children's Dye-Free Allergy

CHILDRENS DYE FREE ALLERGY
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49580-0293
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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49580-0293-4	1 in 1 BOX	02/28/2015
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 final	part341	02/28/2015

Labeler - P & L Development, LLC (101896231)

Revised: 12/2022

Document Id: 1a0cb954-0db0-4a9f-82ea-3e4fb22e9d8e

Set id: 1c4d09ed-4e0f-430d-b17f-6a23f996a55d

Version: 5

Effective Time: 20221212

P & L Development, LLC