PEDIACARE CHILDRENS ALLERGY- diphenhydramine hcl liquid
Prestige Brands Holdings, Inc.

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.

----------

PediaCare Childrens Allergy

PediaCare Children’s Allergy Cherry Flavor

Drug Facts

Active ingredient

(in each 5 mL)*

Diphenhydramine HCI 12.5 mg

Purpose

Antihistamine/cough suppressant

*5 mL = one teaspoon

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
temporarily relieves cough due to inhaled irritants

Warnings

Do not use

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

Ask a doctor before use

if the child has

persistent or chronic cough such as occurs with asthma
cough accompanied by excessive phlegm (mucus)
a breathing problem such as chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use

if the child is taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

cough gets worse or lasts for more than 7 days
cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

find right dose on chart below
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
if needed, repeat dose every 4 hours
do not use more than 6 times in 24 hours

Age (yr)	Dose (tsp)
Under 4 years	Do not use
4 to 5 years	Do not use unless directed by a doctor
6 to 11 years	1 teaspoonful

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each teaspoon contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

call 1-888-474-3099

PediaCare Children’s Allergy Bubblegum Flavor

Drug Facts

Active ingredient

(in each 5 mL, 1 teaspoon)

Diphenhydramine HCI 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

Warnings

Do not use

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

Ask a doctor before use

if the child has

glaucoma
a breathing problem such as chronic bronchitis

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, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take every 4 to 6 hours
do not take more than 6 doses in 24 hours
tsp = teaspoon, mL = milliliter, mg = milligram

Age (yr)	Dose (tsp)
children 6 to 11 years	1 to 2 teaspoonfuls (5 mL to 10 mL)
children 4 to 5 years	Do not use unless directed by a doctor
children under 4 years	do not use

Other information

each teaspoon contains: sodium 6 mg
store at room temperature

Inactive ingredients

citric acid, flavors, glycerin, poloxamer 407, purified water, red 33, red 40, sodium benzoate, sodium chloride, sodium citrate, sugar

Questions or comments?

call 1-888-474-3099

Principal Display Panel

See New Warnings & Directions
PediaCare®Children’s Allergy
Diphenhydramine HCI oral solution
Antihistamine/Cough suppressant
Cherry Flavor Liquid 4 FL OZ (118 mL)

Principal Display Panel

NO ACETAMINOPHEN
PediaCare®Children’s Allergy
Diphenhydramine HCI Oral Solution Antihistamine
BubbleGum Flavor 4 FL OZ (118 mL)

PEDIACARE CHILDRENS ALLERGY
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-399
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)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-399-04	1 in 1 CARTON	10/29/2009	08/31/2017
1		118 mL in 1 BOTTLE; 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	10/29/2009	08/31/2017

PEDIACARE CHILDRENS ALLERGY
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-499
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-499-04	1 in 1 CARTON	02/01/2010	08/31/2017
1		118 mL in 1 BOTTLE; 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	02/01/2010	08/31/2017

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 1/2011

Document Id: ba401a02-eb15-40b7-8c37-8b6e33c13422

Set id: eff380b3-0bbf-431b-bbd1-354c05c6deb2

Version: 3

Effective Time: 20110117

Prestige Brands Holdings, Inc.