58602-825 : Guaifenesin and Dextromethorphan Hbr Oral Tablet, Extended Release

NDC:	58602-825
Labeler:	Aurohealth LLC
Product Type:	Human OTC Drug
Drug Name:	Guaifenesin and Dextromethorphan Hbr
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA206941
Rev. Date:	Mar 17, 2017

Appearance:

Markings:	X;63
Shapes:	Oval
Colors:	White
Size (mm):	22
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

58602-825-06: 6 BLISTER PACK IN 1 CARTON (58602‑825‑06) > 7 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK
58602-825-65: 2 BLISTER PACK IN 1 CARTON (58602‑825‑65) > 7 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

Guaifenesin
Dextromethorphan Hydrobromide

Dosage Strength:

1200 mg
60 mg

Inactive Ingredients:

Silicon Dioxide
Hypromellose, Unspecified
Magnesium Stearate
Microcrystalline Cellulose
Povidone K90
Povidone K25
Starch, Corn /

Pharmaceutical Classes:

Decreased Respiratory Secretion Viscosity [PE]
Expectorant [EPC]
Increased Respiratory Secretions [PE]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]

NDC QR Code

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NDC 58602-825 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.