CHILDRENS ALLERGY- diphenhydramine hcl liquid
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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 product containing diphenhydramine, even one used on the 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 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 6 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.
protect from light. Store in outer carton until contents are used

Inactive ingredients

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

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:

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Pine Bluff, AR 71603 USA

AC (870) 535-3635

MADE IN THE USA

Package Label

Select Brand Children's Allergy

CHILDRENS ALLERGY
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-292
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15127-292-04	1 in 1 BOX	12/31/2015	12/30/2021
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	12/31/2015	12/30/2021

Labeler - Select Brand Dist. (012578514)

Revised: 10/2019

Document Id: bf833ee0-6201-4df3-93cd-c6224f443a56

Set id: 876b7cba-368b-49c9-9538-08ced23fc907

Version: 3

Effective Time: 20191017

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