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Pediacare Childrens Cough And Congestion

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Strides Pharma Inc
NDC Code: 59556-850

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 COUGH AND CONGESTION - dextromethorphan hydrobromide
and guaifenesin liquid

Drug Facts

Active ingredients

(in each 5 mL)

Dextromehorphan HBr, 5 mg

Guaifenesin, 100 mg

Purpose

Dextromehorphan HBr, 5 mg…….Cough suppressant

Guaifenesin, 100 mg…….………..Expectorant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep

Warnings

Do not use for 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

  • cough that occurs with excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma or chronic bronchitis

Stop use and ask a doctor if
  • cough gets worse or last more than 7 days
  • cough comes back or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

When using this product do not use more than directed

Keep out of reach of children

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

Directions
  • this product does not contain directions or complete warnings for adult use
  • use only the dosing cup provided
  • do not exceed 6 doses in a 24-hour period
  • mL = milliliter
Age (yrs)
Dose (ml)
under 4 years
do not use
4 to under 6 yrs
2.5-5 mL every 4 hours
6 to 11 yrs
5-10 mL every 4 hours

Other information
  • each 5 mL contains:sodium 3 mg
  • store at room temperature
  • dosage cup provided

Inactive ingredients

acesulfame potassium, citric acid, FD&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium chloride, sodium citrate, sucralose, sucrose

Questions?

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PediaCare.com

PRINCIPAL DISPLAY PANEL

PediaCare® Children Cough & Congestion

Non Drowsy

4 FL OZ FL (118 mL)

Cherry Flavor

Carton

Container Label - Top

Container Label - Base

Container Label - Back

PEDIACARE CHILDRENS COUGH AND CONGESTION 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-850
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
ACESULFAME POTASSIUM 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
AMMONIUM GLYCYRRHIZATE 
POLOXAMER 407 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCRALOSE 
SUCROSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-850-58118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2010
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245MANUFACTURE(59556-850), ANALYSIS(59556-850), LABEL(59556-850), PACK(59556-850)

Revised: 08/2017
 
Strides Pharma 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.

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