Label: GUAIFENESIN tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 51316-070-68 - Packager: CVS PHARMACY, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each extended-release tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-070 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, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code Mxeunic;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-070-68 4 in 1 CARTON 02/09/2021 1 17 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 NDA NDA021282 02/09/2021 Labeler - CVS PHARMACY, INC (062312574) Establishment Name Address ID/FEI Business Operations RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD 230780363 MANUFACTURE(51316-070)