Label: GUAIFENESIN EXTENDED-RELEASE- guaifenesin tablet, multilayer, extended release
- NDC Code(s): 68094-048-59, 68094-048-61
- Packager: Precision Dose Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-2023
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 27, 2025
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SPL UNCLASSIFIED SECTIONTablets, 600 mg - For Hospital Use Only - LI1730 Rev. 10/24
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active ingredient (in each extended-release tablet)Guaifenesin 600 mg
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PurposeExpectorant
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Useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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WarningsDo not use - for children under 12 years of age - Ask a doctor before use if you have - persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema - cough ...
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DirectionsUse as directed per healthcare professional. 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 ...
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Other informationstore at 20-25°C (68-77°F)
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Inactive ingredientsCarbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
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Questions or comments?1-800-397-9228
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SPL UNCLASSIFIED SECTIONGluten Free
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How SuppliedNDC 68094-048-61 - Unit Dose Packages of 100 Tablets (10×10) per Carton
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SPL UNCLASSIFIED SECTIONPackaged by: Precision Dose, Inc. South Beloit, IL 61080 - For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com - LI1730 Rev. 10/24
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PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack CartonPrecisionDose™ NDC 68094-048-61 - Unit Dose - guaiFENesin - Extended-Release - Tablets, 600 mg - 100 Tablets - (10 x 10) (in each extended-release tablet) Guaifenesin 600 mg....Expectorant. Directions: do not ...
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INGREDIENTS AND APPEARANCEProduct Information