Childrens Mucinex Cough

Generic Name: guaifenesin and dextromethorphan hydrobromide
Dosage Form: oral solution

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.

Children's
Mucinex®
Cough

Drug Facts

Active ingredients
(in each 5 mL)
Purpose
Dextromethorphan 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 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.

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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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL – 10 mL every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours
children under 4 years do not use

Other information

  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

citric acid anhydrous, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

PRINCIPAL DISPLAY PANEL - 188 mL Bottle Carton

Children's
Mucinex®

Cough

Expectorant
Cough Suppressant

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg

Cough
Chest Congestion
Breaks up Mucus

Cherry
Flavor Liquid

4 FL OZ
(118 mL)

NDC 54868-6125-0

Childrens Mucinex Cough 
guaifenesin and dextromethorphan hydrobromide solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6125(NDC:63824-274)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID  
DEXTROSE  
D&C RED NO. 33  
FD&C RED NO. 40  
GLYCERIN  
METHYLPARABEN  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SACCHARIN SODIUM  
SODIUM HYDROXIDE  
SUCRALOSE  
XANTHAN GUM  
Product Characteristics
Color pink Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:54868-6125-0 1 BOTTLE (BOTTLE) in 1 CARTON
1 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/19/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel
Revised: 09/2010
 
Physicians Total Care, Inc.



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