Label: GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release
- NDC Code(s): 68196-996-56
- Packager: SAM'S WEST INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 24, 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
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Warnings
Ask a doctor before use if you have
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough accompanied by too much phlegm (mucus)
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Directions
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- do not crush, chew, or break extended-release tablet
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- take with a full glass of water
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- this product can be administered without regard for the timing of meals
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- adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
GUAIFENESIN EXTENDED RELEASE
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-996 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 hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) silicon dioxide (UNII: ETJ7Z6XBU4) povidone, unspecified (UNII: FZ989GH94E) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color WHITE Score no score Shape OVAL Size 22mm Flavor Imprint Code RH;99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-996-56 4 in 1 CARTON 01/12/2022 1 14 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 01/12/2022 Labeler - SAM'S WEST INC (051957769) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(68196-996)