Label: GUAIFENESIN EXTENDED-RELEASE 600 MG- guaifenesin tablet, extended release
GUAIFENESIN EXTENDED-RELEASE 1200 MG- guaifenesin tablet, extended release
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NDC Code(s):
53041-233-30,
53041-233-32,
53041-233-38,
53041-234-37, view more53041-234-47, 53041-234-58
- Packager: Guardian Drug Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 28, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each extended-release tablet)
- PURPOSE
- USE(S)
- WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND A ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- ACTIVE INGREDIENT (in each extended-release tablet)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- 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?
- PRINCIPAL DISPLAY PANEL 600 MG
- PRINCIPAL DISPLAY PANEL 1200 MG
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INGREDIENTS AND APPEARANCE
GUAIFENESIN EXTENDED-RELEASE 600 MG
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53041-233 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) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code G233 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53041-233-32 2 in 1 CARTON 03/01/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:53041-233-30 1 in 1 CARTON 03/01/2018 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:53041-233-38 4 in 1 CARTON 03/01/2018 3 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 ANDA209215 03/01/2018 GUAIFENESIN EXTENDED-RELEASE 1200 MG
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53041-234 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 TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code G234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53041-234-58 2 in 1 CARTON 03/01/2018 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:53041-234-37 4 in 1 CARTON 03/01/2018 2 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:53041-234-47 6 in 1 CARTON 03/01/2018 3 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 ANDA209215 03/01/2018 Labeler - Guardian Drug Company (119210276) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(53041-233, 53041-234)