PEDIACARE CHILDRENS NIGHTTIME MULTI SYMPTOM COLD- diphenhydramine, phenylephrine liquid
Medtech Products 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.

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Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/Cough suppressant

Nasal decongestant

Uses

temporarily relieves:

sneezing
runny nose
itchy nose or throat
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

to make a child sleepy
in a child under 4 years of age
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

glaucoma
heart disease
high blood pressure
diabetes
thyroid disease
a breathing problem such as chronic bronchitis
chronic cough that lasts, or as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

do not exceed recommended dose
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

Keep out of reach of children.

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 give more than 6 times in 24 hours unless directed by a doctor
tsp = teaspoon; mL = milliliter

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

Other information

each teaspoon (5 mL) contains: sodium 6 mg
store at room temperature. Protect from light. Store in outer carton until contents are used.
see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, benzoic acid, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, maltitol solution, propylene glycol, purified water, sodium citrate

Questions or comments?

1-888-474-3099

Principal Display Panel

CHILDREN Ages 6-11

PediaCare

Childrens NIGHTTIME MULTI-SYMPTOM Cold

Relieves Stuffy Nose

Soothes Itchy Throat

Controls Cough

Diphenhydramine HCl

Antihistamine/Cough suppressant

Phenylephrine HCl

Nasal decongestant

Grape Flavor

FL OZ (mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING

KEEP THIS BOX FOR COMPLETE INSTRUCTIONS.

Distributed by Medtech Products Inc.

Irvington, NY 10533, a Prestige Brands Company

Made in USA

www.PediaCare.com

Package Label

Diphenhydramine HCl 6.25 mg; Phenylephrine HCl 2.5 mg

PediaCare Childrens Nighttime Multi-Symptom Cold Grape Liquid

PEDIACARE CHILDRENS NIGHTTIME MULTI SYMPTOM COLD
diphenhydramine, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63029-435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-435-04	1 in 1 BOX	06/20/2012	12/31/2017
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	06/20/2012	12/31/2017

Labeler - Medtech Products Inc (122715688)

Revised: 10/2017

Document Id: 45589fef-379a-42aa-a343-9f60cda2630d

Set id: e9432ccf-e0c6-4286-82f2-5a6a10bb5893

Version: 2

Effective Time: 20171025

Medtech Products Inc