PediaCare Childrens Cough and Congestion

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-395

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

Drug Facts

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
agedose
children 6 years to under 12 years1 – 2 teaspoonfuls (tsps) every 4 hours
children 4 years to 6 years½ - 1 teaspoonful (tsp) every 4 hours
children under 4 yearsdo 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)

PEDIACARE CHILDRENS COUGH AND CONGESTION 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-395
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
ANHYDROUS CITRIC ACID 
DEXTROSE 
GLYCERIN 
METHYLPARABEN 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
D&C RED NO. 33 
FD&C RED NO. 40 
SACCHARIN SODIUM 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-395-041 BOTTLE (1 BOTTLE) in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Aaron Industries113044205MANUFACTURE

Revised: 10/2010
 
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 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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