Your browser does not support JavaScript! CHILDRENS MUCINEX CHEST CONGESTION (GUAIFENESIN) LIQUID [RECKITT BENCKISER LLC]
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CHILDRENS MUCINEX CHEST CONGESTION (guaifenesin) liquid
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • 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
AgeDose
children 6 years to under 12 years5 mL – 10 mL
every 4 hours
children 4 years to under 6 years2.5 mL – 5 mL
every 4 hours
children under 4 yearsdo 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, 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-280
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
anhydrous citric acid 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
maltitol 
propylene glycol 
water 
saccharin sodium 
sodium benzoate 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-280-641 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2011
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

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