Label: MUCINEX D MAXIMUM STRENGTH- guaifenesin and pseudoephedrine hydrochloride tablet, extended release
- NDC Code(s): 63824-041-12, 63824-041-24, 63824-041-36, 63824-041-71
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 11, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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Warnings
Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- 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 - 24 Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
MUCINEX D MAXIMUM STRENGTH
guaifenesin and pseudoephedrine hydrochloride tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-041 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color orange, 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:63824-041-24 2 in 1 CARTON 06/26/2012 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-041-71 24 in 1 CARTON 06/26/2012 07/10/2017 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:63824-041-36 3 in 1 CARTON 06/26/2012 09/12/2017 3 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:63824-041-12 1 in 1 CARTON 01/01/2020 12/31/2022 4 12 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 NDA021585 06/26/2012 Labeler - RB Health (US) LLC (081049410)