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NDC 52083-0600-16 G-ZYNCOF 20; 400 mg/5mL; mg/5mL Details
G-ZYNCOF 20; 400 mg/5mL; mg/5mL
G-ZYNCOF is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. 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: 52083-0600-16Last Updated: 11/30/2022
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: 52083-0600-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 52083-0600 |
|---|---|
| Product ID | 52083-600_0aeed24e-ca81-4f3e-b98c-31857395fd4b |
| Associated GPIs | 43997002521280 |
| GCN Sequence Number | 067618 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 400-20MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 30209 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | G-ZYNCOF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 20; 400 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0600-16 (52083060016)
| NDC Package Code | 52083-600-16 |
|---|---|
| Billing NDC | 52083060016 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (52083-600-16) |
| Marketing Start Date | 2012-12-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc Details
Uses
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
SPL UNCLASSIFIED SECTION
Keep out of reach of children.
Directions
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| G-ZYNCOF
dextromethorphan hbr and guaifenesin syrup |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |