Label: MUCINEX- guaifenesin tablet, extended release
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NDC Code(s):
63824-008-15,
63824-008-17,
63824-008-24,
63824-008-27, view more63824-008-32, 63824-008-34, 63824-008-36, 63824-008-50, 63824-008-69, 63824-008-72, 63824-008-73, 63824-008-74, 63824-008-80, 63824-008-86, 63824-008-92
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated September 7, 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
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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 - 20 Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
MUCINEX
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 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) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (blue and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-008-36 1 in 1 CARTON 07/03/2012 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-008-32 1 in 1 CARTON 07/03/2012 2 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-008-34 2 in 1 CARTON 07/03/2012 3 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:63824-008-69 3 in 1 CARTON 07/03/2012 4 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:63824-008-27 4 in 1 CARTON 07/03/2012 5 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:63824-008-15 5 in 1 CARTON 07/03/2012 6 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:63824-008-74 24 in 1 CARTON 07/03/2012 7 NDC:63824-008-73 2 in 1 POUCH; Type 0: Not a Combination Product 8 NDC:63824-008-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/03/2012 9 NDC:63824-008-72 2 in 1 POUCH; Type 0: Not a Combination Product 07/03/2012 10 NDC:63824-008-86 4 in 1 CARTON 07/03/2012 10 17 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:63824-008-24 2 in 1 CARTON 07/03/2012 06/15/2022 11 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 12 NDC:63824-008-80 4 in 1 CARTON 07/03/2012 12 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 13 NDC:63824-008-92 6 in 1 CARTON 07/03/2012 13 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 14 NDC:63824-008-17 25 in 1 CARTON 10/01/2018 12/31/2020 14 NDC:63824-008-72 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021282 07/03/2012 Labeler - RB Health (US) LLC (081049410)