Label: MUCUS RELIEF EXTENDED RELEASE- guaifenesin tablet
- NDC Code(s): 55154-4153-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-6718
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 12, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each extended-release tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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- cough accompanied by too much phlegm (mucus)
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Directions
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- do not crush, chew, or break tablet
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- take with a full glass of water
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- this product can be administered without regard for the timing of meals
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- adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF EXTENDED RELEASE
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4153(NDC:0904-6718) 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BLUE Score no score Shape OVAL Size 16mm Flavor Imprint Code AN036 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-4153-0 10 in 1 BAG 09/30/2018 1 1 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 ANDA ANDA207342 09/30/2018 Labeler - Cardinal Health 107, LLC (118546603) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 828269675 REPACK(55154-4153)