MUCINEX CHILDRENS COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension

Mucinex Childrens Cough and Congestion by

Drug Labeling and Warnings

Mucinex Childrens Cough and Congestion by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts
ACTIVE INGREDIENT

Active ingredients (in each 5 mL) Purposes

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
- nervousness, dizziness, or sleeplessness occur
- 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 condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not give 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
Age Dose

children 6 to under 12 years of age 10 mL every 4 hours

children 4 to under 6 years of age 5 mL every 4 hours

children under 4 years of age do not use
Other information
- each 5 mL contains: sodium 3 mg
- store between 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Age	Dose
children 6 to under 12 years of age	10 mL every 4 hours
children 4 to under 6 years of age	5 mL every 4 hours
children under 4 years of age	do not use

Questions?

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

You may also report side effects to this phone number.

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

Made in England

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

VALUE SIZE

Pediatrician Recommended†

NDC: 63824-947-11

Mucinex®
Children's

COUGH &
CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant

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

Ages
4+ yrs

Very Berry
Flavor Liquid

6.8 FL OZ (201 mL)

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS COUGH AND CONGESTION
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-947
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 63824-947-11	1 in 1 CARTON	03/30/2018
1		201 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/30/2018

Labeler - Reckitt Benckiser LLC (094405024)