PEDIACARE CHILDRENS COUGH AND CONGESTION- dextromethorphan hydrobromide and guaifenesin liquid 
Blacksmith Brands, 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

Active ingredients

(in each 5 mL, 1 teaspoon)

Dextromehorphan HBr, USP 5 mg

Purpose

Cough suppressant

Active ingredients

(in each 5 mL, 1 teaspoon)

Guaifenesin, USP 100 mg

Purpose

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 too much 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 lasts more than 7 days
  • cough comes back or occurs with fever, rash, or headache that lasts.
    These could be signs of a serious illness.

When using this product

  • do not use more than directed

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • tsp = teaspoon, mL = milliliter
  • this product does not contain directions or complete warnings for adult use
  • do not exceed 6 doses in a 24-hour period
 age dose
 children 6 years to under 12 years 1 – 2 teaspoonfuls (tsps) every 4 hours
 children 4 years to 6 years ½ - 1 teaspoonful (tsp) every 4 hours
 children under 4 years do not use

Other information

  • each teaspoon contains: sodium 3 mg
  • store at room temperature
  • dosage cup provided

Inactive ingredients

citric acid anhydrous, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Questions or comments?

call 1-888-474-3099

PRINCIPAL DISPLAY PANEL

NO ACETAMINOPHEN
PediaCare Children’s Cough & Congestion
Luden’s Cherry Taste!
4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL PediaCare Children’s Cough & Congestion Cherry Flavor
PEDIACARE CHILDRENS COUGH AND CONGESTION 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-395
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-395-041 in 1 BOX07/12/201006/06/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/201006/06/2017
Labeler - Blacksmith Brands, Inc. (159655021)

Revised: 9/2017
Document Id: 3f60b695-9279-445a-b58d-af2f9c19bc57
Set id: 4772d9a5-85f1-4ca9-a240-84d733dcd86e
Version: 3
Effective Time: 20170922
 
Blacksmith Brands, Inc.