Label: MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
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NDC Code(s):
63824-023-02,
63824-023-07,
63824-023-18,
63824-023-35, view more63824-023-36, 63824-023-46, 63824-023-48, 63824-023-56
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 16, 2022
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
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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
- PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
MUCINEX MAXIMUM STRENGTH
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:63824-023-07 1 in 1 CARTON 06/11/2015 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-023-35 1 in 1 CARTON 06/26/2012 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-023-36 2 in 1 CARTON 06/26/2012 3 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:63824-023-48 4 in 1 CARTON 06/26/2012 4 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:63824-023-46 3 in 1 CARTON 06/26/2012 5 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:63824-023-18 2 in 1 CARTON 06/26/2012 06/15/2022 6 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:63824-023-02 1 in 1 CARTON 07/01/2021 7 1 in 1 POUCH; Type 0: Not a Combination Product 8 NDC:63824-023-56 4 in 1 CARTON 07/01/2021 8 14 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 - RB Health (US) LLC (081049410)