CHILDRENS MUCINEX  CHEST CONGESTION- guaifenesin solution 
RB Health (US) 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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Children's
Mucinex®
Chest
Congestion

Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin 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

  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

citric acid anhydrous, dextrose, FD&C blue #1, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, 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

Children's
Mucinex®

Chest
Congestion
Expectorant
Guaifenesin Oral Solution, USP

✔
Chest Congestion
✔
Breaks up Mucus

Grape
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
CHILDRENS MUCINEX   CHEST CONGESTION
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-473
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
potassium sorbate (UNII: 1VPU26JZZ4)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium hydroxide (UNII: 55X04QC32I)  
sucralose (UNII: 96K6UQ3ZD4)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-473-641 in 1 CARTON06/22/201012/12/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/22/201012/12/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2018
Document Id: 26450946-253c-449a-b697-5a77a609be1f
Set id: 89c1956f-efbe-4d5b-b34b-854d680efc76
Version: 2
Effective Time: 20181218
 
RB Health (US) LLC