CHILDRENS MUCINEX COUGH- guaifenesin and dextromethorphan hydrobromide liquid 
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)Purpose
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

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, xanthan gum

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-281-64

Children's
Mucinex
®

Cough

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg

Expectorant
Cough Suppressant

✓Cough
✓Chest Congestion
✓Breaks up Mucus
✓Alcohol-free

Cherry
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
CHILDRENS MUCINEX COUGH 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-281
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-281-641 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2012
Document Id: f55f7917-4250-47d0-9ec7-27f2e2eaae42
Set id: ce565113-e9e3-46de-84f7-3a432acb0e4b
Version: 2
Effective Time: 20121109
 
Reckitt Benckiser LLC