Label: MUCUS RELIEF- guaifenesin tablet, extended release
- NDC Code(s): 80513-403-20
- Packager: Advanced Rx LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 29, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient(in each extended-release tablet)
- Purpose
- Uses
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WARNINGS
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)
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Directions
■ do not crush, chew, or break tablet
■ take with a full glass of water
■ this product can be administered without regard for the timing of meals
■ adults and children 12 years of age and over:1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
■ children under 12 years of age:do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80513-403 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code G;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80513-403-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213420 05/08/2020 Labeler - Advanced Rx LLC (042795108)