PEDIACARE CHILDRENS COUGH AND CONGESTION- dextromethorphan hydrobromide and guaifenesin liquid 
Strides Pharma 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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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

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

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

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

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?

1-888-474-3099

Monday - Friday 8 am to 8 pm EST

PediaCare.com

PRINCIPAL DISPLAY PANEL

PediaCare® Children Cough & Congestion

Non Drowsy

4 FL OZ FL (118 mL)

Cherry Flavor

Carton

Carton

Container Label - Top

Container Label - Top

Container Label - Base

Container Label - Base

Container Label - Back

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
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)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-850-58118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2010
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Richmond, Inc.969523245MANUFACTURE(59556-850) , ANALYSIS(59556-850) , LABEL(59556-850) , PACK(59556-850)

Revised: 8/2017
Document Id: f65dc1fd-8443-4a2f-8a9c-65f6cf6ca50f
Set id: 921b7b7f-3613-41a0-b626-5d7c0f17f7be
Version: 1
Effective Time: 20170804
 
Strides Pharma Inc