Label: SIMPEX GUAIFENESIN- guaifenesin tablet
- NDC Code(s): 76457-004-00
- Packager: Simpex Pharma Pvt. Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Uses
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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 with excessive phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SIMPEX GUAIFENESIN
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76457-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color red (Iron oxide red, Iron oxide yellow) Score no score Shape ROUND (Biconvex) Size 6mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76457-004-00 100 in 1 CARTON; Type 0: Not a Combination Product 02/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/09/2018 Labeler - Simpex Pharma Pvt. Ltd (916758275) Establishment Name Address ID/FEI Business Operations Simpex Pharma Pvt. Ltd 916758275 manufacture(76457-004)