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PediaCare Childrens MultiSymptom Cold

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Blacksmith Brands, 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

*5 mL = one teaspoon

Use 
  • temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
  • cough
  • nasal congestion

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 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.
  • if needed, repeat dose every 4 hours
  • do not give more than 6 times in 24 hours

Do not use any other dosing device.

AgeDoes (tsp)
Under 4 yearsDo not use
4 to 5 years1 teaspoonful (5 mL)
6 to 11 years2 teaspoonfuls (10 mL)

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 15 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are 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, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments? 

call 1-888-474-3099

Principal Display Panel  

PediaCare
Children’s Multi-Symptom Cold

Phenylephrine HCI, Dextromethorphan HBr
Grape
Flavor Liquid

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 - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Trillium Healthcare Products, Inc.255426306MANUFACTURE

Revised: 07/2010
 
Blacksmith Brands, 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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