Label: GUAIFENESIN, DEXTROMETHORPHAN HBR capsule, liquid filled
- NDC Code(s): 69729-783-02
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 17, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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WARNINGS
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.
If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.Ask a doctor before use if you have
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smooking, asthma, chronic bronchitis, or emphysema - Directions
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUAIFENESIN, DEXTROMETHORPHAN HBR
guaifenesin, dextromethorphan hbr capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-783 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL SOLUTION (UNII: 8KW3E207O2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow (LIGHT YELLOW) Score no score Shape OVAL (Oblong) Size 20mm Flavor Imprint Code 781 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-783-02 2 in 1 CARTON 02/18/2019 1 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 OTC Monograph Drug M012 02/18/2019 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LIMITED 677385498 manufacture(69729-783)