Label: MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
- NDC Code(s): 50090-2301-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 63824-023
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated September 10, 2023
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 extended-release bi-layer tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- Guaifenesin
-
INGREDIENTS AND APPEARANCE
MUCINEX MAXIMUM STRENGTH
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2301(NDC:63824-023) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) Product Characteristics Color WHITE (blue and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2301-0 1 in 1 CARTON 02/11/2016 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021282 06/26/2012 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-2301)