ZYNCOF 20; 400 mg/5mL; mg/5mL
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: 52083-0400-04
Last 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: 52083-0400-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
- Product Information
- Package Information
Images
- Prescribing Information
Product Information
| NDC | 52083-0400 |
|---|---|
| Product ID | 52083-400_0ce3d63e-43c0-43d9-a1ff-cb48da835eee |
| 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 | 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 52083-0400-04 (52083040004)
| NDC Package Code | 52083-400-04 |
|---|---|
| Billing NDC | 52083040004 |
| Package | 120 mL in 1 BOTTLE, PLASTIC (52083-400-04) |
| Marketing Start Date | 2011-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
<< 52083-0400-01 52083-0400-16 >>
Contents
- Product Information
- Package Information
Images
- Prescribing Information
Standard Product Labeling (SPL)/Prescribing Information SPL cffd6d5f-0cb2-4d38-bdb0-6a21120418cc Details
Active ingredients (in each 5 mL tsp)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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 smoking, asthma, chronic bronchitis, or emphysema
When using this product do not use more than directed.
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- EVERY 4 HOURS
- Adults and Children 12 years of age and over 5 mL (1 tsp)
- Children under 12 years of age consult physician
Other information
- Tamper evident feature: Do not use if inner seal is torn, broken or missing.
- Store at controlled room temperature 15°-30°C (59° to 86°F).
- Avoid excessive heat or humidity.
Inactive ingredients
Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.
SPL UNCLASSIFIED SECTION
Made in the USA for Kramer Novis.
San Juan, PR 00917
(787) 767-2072 / www.kramernovis.com
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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Labeler -Kramer Novis(090158395)
Revised: 7/2015
Document Id: 0ce3d63e-43c0-43d9-a1ff-cb48da835eee
Set id: cffd6d5f-0cb2-4d38-bdb0-6a21120418cc
Version: 3
Effective Time: 20150702
