PediaCare Childrens MultiSymptom Cold

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Prestige Brands Holdings, Inc.
NDC Code: 52183-359

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 Multi-Symptom Cold

PediaCare Children’s Multi-Symptom Cold

Drug Facts

Active ingredients

(in each 5 mL)*

Dextromethorphan HBr 5 mg

Purpose 

Cough suppressant

Active ingredients

(in each 5 mL)*

Phenylephrine HCl 2.5 mg

Purpose 

Nasal decongestant

Use 

temporarily relieves

  • cough and nasal congestion due to common cold
  • nasal congestion due to hay fever or other upper respiratory allergies

Warnings  

Do not use 
  • 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.

Ask a doctor before use

if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a persistent or chronic cough such as occurs with asthma
  • a cough accompanied by excessive phlegm (mucus)
  • a sodium-restricted diet

When using this product

do not exceed recommended dose

Stop use and ask a doctor if  
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • cough gets worse or lasts for more than 7 days
  • cough tends to come back or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

Keep out of reach of children  

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

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
  • mL = milliliter
Age (yrs)Dose (mL)
under 4 yearsdo not use
4 to 5 years5 mL
6 to 11 years10 mL

Other information  
  • each 5 mL contains: sodium 15 mg
  • store between 68-77°F (20-25°C). Protect from light. Store in outer carton until contents are used.
  • see bottom panel for lot number and expiration date

Inactive ingredients  

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions?

1-888-474-3099 Mon. –Fri. 8 am to 8 pm EST PediaCare.com

Principal Display Panel  

CHILDREN
Ages 4-11

PediaCare
DAYTIME

Multi
-Symptom Cold
Phenylephrine HCI
Nasal decongestant

Dextromethorphan HBr
Cough suppressant

NON-DROWSY

Grape Flavor
4 FL OZ (118
mL)

PEDIACARE CHILDRENS MULTISYMPTOM COLD 
dextromethorphan hbr and phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-359
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-359-041 BOTTLE (1 BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/2009
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245MANUFACTURE(52183-359)

Revised: 02/2014
 
Prestige Brands Holdings, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)