CHILDRENS MUCINEX COUGH- guaifenesin and dextromethorphan hydrobromide liquid

Childrens Mucinex Cough by

Drug Labeling and Warnings

Childrens Mucinex Cough by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients (in each 5 mL): Purpose
• Dextromethorphan HBr 5 mg: Cough suppressant
• Guaifenesin 100 mg: Expectorant

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

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

• 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
• mL = milliliter

Age	Dose
children 6 years to under 12 years	5 mL – 10 mL every 4 hours
children 4 years to under 6 years	2.5 mL – 5 mL every 4 hours
children under 4 years	do not use

Other information

• tamper evident: do not use if printed neckband on bottle cap is broken or missing
• store between 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

CHILDRENS MUCINEX COUGH 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-281
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-281-64	1 in 1 CARTON
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2011

Labeler - Reckitt Benckiser LLC (094405024)