Label: CHILDRENS MUCINEX CHEST CONGESTION- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63824-280-64 - Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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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
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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 hourschildren 4 years to under 6 years 2.5 mL – 5 mL
every 4 hourschildren under 4 years do not use - Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CHILDRENS MUCINEX CHEST CONGESTION
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-280 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 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)