Label: GUAIFENESIN tablet, extended release
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NDC Code(s):
58602-811-01,
58602-811-02,
58602-811-03,
58602-811-05, view more58602-811-12, 58602-811-21, 58602-811-56, 58602-811-57, 58602-811-60, 58602-811-64, 58602-811-73
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 29, 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 - 1200 mg (20 Tablet Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Carton Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-811 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 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 21mm Flavor Imprint Code L;69 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-811-05 1 in 1 CARTON 10/21/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-811-73 1 in 1 CARTON 10/21/2019 2 20 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-811-57 1 in 1 CARTON 10/21/2019 3 28 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-811-12 1 in 1 CARTON 10/21/2019 4 40 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-811-60 1 in 1 CARTON 10/21/2019 5 42 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-811-21 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/21/2019 7 NDC:58602-811-01 1 in 1 CARTON 10/21/2019 7 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:58602-811-02 2 in 1 CARTON 10/21/2019 8 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:58602-811-03 3 in 1 CARTON 10/21/2019 9 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:58602-811-56 4 in 1 CARTON 01/31/2020 10 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:58602-811-64 1 in 1 CARTON 11/26/2020 11 7 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 10/21/2019 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(58602-811) , MANUFACTURE(58602-811)