Label: GUAIFENESIN tablet, extended release
- NDC Code(s): 0363-0028-96, 0363-0028-97, 0363-0028-98
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 24, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg 20 (1 x 20) Tablets
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0028 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POVIDONE K90 (UNII: RDH86HJV5Z) POVIDONE K25 (UNII: K0KQV10C35) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 16mm Flavor Imprint Code L;68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0028-96 1 in 1 CARTON 05/08/2020 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0028-97 2 in 1 CARTON 05/08/2020 2 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0363-0028-98 5 in 1 CARTON 05/08/2020 3 20 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 ANDA210453 05/08/2020 Labeler - WALGREEN CO. (008965063) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(0363-0028) , MANUFACTURE(0363-0028)