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NDC 43598-0115-37 Guaifenesin and Dextromethorphan HBR 60; 1200 mg/1; mg/1 Details
Guaifenesin and Dextromethorphan HBR 60; 1200 mg/1; mg/1
Guaifenesin and Dextromethorphan HBR is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 43598-0115-37Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 43598-0115-37Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Guaifenesin
Product Information
NDC | 43598-0115 |
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Product ID | 43598-115_c4b32a9e-981c-1f4f-944a-11ad9807caeb |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Guaifenesin and Dextromethorphan HBR |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Guaifenesin and Dextromethorphan HBR |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 60; 1200 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
Labeler Name | Dr. Reddy's Laboratories Inc. |
Pharmaceutical Class | 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 Ant |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA217340 |
Listing Certified Through | 2024-12-31 |
Package
NDC 43598-0115-37 (43598011537)
NDC Package Code | 43598-115-37 |
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Billing NDC | 43598011537 |
Package | 3 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) |
Marketing Start Date | 2023-08-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |