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

Childrens Mucinex by

Drug Labeling and Warnings

Childrens Mucinex 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)	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

• 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 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

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

Made in England

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

NDC: 63824-283-67

Children's
Mucinex®

Congestion
& Cough

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

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

Age 4+

Berrylicious
Flavor Liquid

6.8 FL OZ
(201 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-283
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
edetate disodium (UNII: 7FLD91C86K)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
propyl gallate (UNII: 8D4SNN7V92)
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	PINK	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-283-67	1 in 1 CARTON
1		201 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/17/2012

Labeler - Reckitt Benckiser LLC (094405024)