CHILDRENS MUCINEX CHEST CONGESTION- guaifenesin liquid 
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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Childrens
Mucinex®
Chest
Congestion

Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

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

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, 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 63824-280-64

Children's
Mucinex®

Chest
Congestion

Guaifenesin Oral Solution, USP
Expectorant

Chest Congestion
Breaks up Mucus
Alcohol-free

Grape
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
CHILDRENS MUCINEX CHEST CONGESTION 
guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-280
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium (UNII: 23OV73Q5G9)  
anhydrous citric acid (UNII: XF417D3PSL)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
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)  
sucralose (UNII: 96K6UQ3ZD4)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-280-64 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)

Revised: 11/2012
Document Id: 65cb02de-aa36-4bce-9045-79448592daae
Set id: 1daa3c05-eaeb-4219-a959-4959750a30a0
Version: 2
Effective Time: 20121109
 
Reckitt Benckiser LLC