Label: GUAIFENESIN tablet, extended release
- NDC Code(s): 51316-071-68
- Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 23, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each extended-release tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
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Directions
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: one or two extended-release tablet every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
- 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:51316-071 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) FD&C blue no. 2--aluminum lake (UNII: 4AQJ3LG584) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) povidone, unspecified (UNII: FZ989GH94E) Product Characteristics Color BLUE, WHITE Score no score Shape OVAL (biconvex) Size 16mm Flavor Imprint Code RH98 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-071-68 1 in 1 CARTON 10/07/2022 1 68 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 ANDA209254 10/07/2022 Labeler - CVS (062312574) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(51316-071)