CHILDRENS MUCINEX MULTI-SYMPTOM COLD - dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride 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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Drug Facts

Active ingredients
(in each 5 mL)
Purpose
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
Pseudoephedrine HCl 2.5 mgNasal decongestant

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • 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 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

Other information

Inactive ingredients

citric acid anhydrous, D&C red #33, dextrose, FD&C blue #1, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

Questions?

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-010-64

Children's
Mucinex
®

Multi-Sympton
Cold

Expectorant
Cough Suppressant
Nasal Decongestant

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg

✓ Stuffy Nose
✓ Cough
✓ Chest Congestion
✓ Breaks up Mucus

Very Berry
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton

CHILDRENS MUCINEX MULTI-SYMPTOM COLD 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-010
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
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
dextrose 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
methylparaben 
potassium sorbate 
propyl gallate 
propylene glycol 
propylparaben 
water 
saccharin sodium 
sodium hydroxide 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63824-010-641 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (63824-010-64)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2011

Labeler - Reckitt Benckiser LLC (094405024)
Establishment
NameAddressID/FEIOperations
SSL International plc217062957PACK, LABEL

Revised: 12/2011 Reckitt Benckiser LLC