CHILDRENS MUCINEX  COUGH- dextromethorphan hydrobromide and guaifenesin solution 
Reckitt Benckiser LLC

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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Children's Mucinex® Cough

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

Uses

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.

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

AgeDose
children 6 years to under 12 years5 mL – 10 mL every 4 hours
children 4 years to under 6 years2.5 mL – 5 mL every 4 hours
children under 4 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum


1
may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

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

Made in England

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-286-64

Children's
Mucinex®

Cough

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Cough Suppressant
Expectorant

Cough
Chest Congestion
Breaks up Mucus
Alcohol-free

Age 4+

Cherry
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
CHILDRENS MUCINEX   COUGH
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-286
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)  
edetate disodium (UNII: 7FLD91C86K)  
FD&C red No. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
propyl gallate (UNII: 8D4SNN7V92)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
trisodium citrate dihydrate (UNII: B22547B95K)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-286-641 in 1 CARTON07/13/2012
1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/13/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 9/2016
Document Id: 81e4cc48-39a1-4760-8668-a78463d696e5
Set id: a6c2fe13-543d-4bcb-b67b-540be01d7824
Version: 4
Effective Time: 20160902
 
Reckitt Benckiser LLC