Label: GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG- guaifenesin extended-release tablet
GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG- guaifensin extended-release tablet
- NDC Code(s): 62207-697-72, 62207-698-71
- Packager: Granules India Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 16, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for 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(For 600mg)
- adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
- children under 12 years of age: do not use
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- STORAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG
guaifenesin extended-release tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-697 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, UNSPECIFIED TYPE (UNII: 0A5MM307FC) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue (white and blue) 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:62207-697-72 9 in 1 CARTON 09/10/2020 1 10 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 ANDA213420 09/10/2020 GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG
guaifensin extended-release tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-698 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 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue (white-blue) Score no score Shape OVAL Size 22mm Flavor Imprint Code G;1200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-698-71 7 in 1 CARTON 09/10/2020 1 10 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 ANDA213420 09/10/2020 Labeler - Granules India Ltd (915000087) Establishment Name Address ID/FEI Business Operations Granules India Ltd 918609236 manufacture(62207-697, 62207-698) , analysis(62207-697, 62207-698) , pack(62207-697, 62207-698) , label(62207-697, 62207-698)