CHILDRENS MUCINEX MULTI-SYMPTOM COLD - guaifenesin, dextromethorphan hydrobromide 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 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

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
- nasal congestion due to a cold
- stuffy nose

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

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
dose as follows or as directed by a doctor
mL = milliliter

Age	Dose
children 6 years to under 12 years	10 mL every 4 hours
children 4 years to under 6 years	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, 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.

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-010-64

Children's
Mucinex®

Multi-Symptom
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
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-010
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
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	2.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63824-010-64	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		118 mL in 1 BOTTLE	This package is contained within the CARTON (63824-010-64)
2	NDC:63824-010-61	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		30 mL in 1 BOTTLE	This package is contained within the CARTON (63824-010-61)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/04/2011

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2011 Reckitt Benckiser LLC