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NDC 52083-0400-16 ZYNCOF 20; 400 mg/5mL; mg/5mL Details

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: 52083-0400-16
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: 52083-0400-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

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 52083-0400-16 (52083040016)

Pricing Information	N/A
NDC Package Code	52083-400-16
Billing NDC	52083040016
Package	474 mL in 1 BOTTLE, PLASTIC (52083-400-16)
Marketing Start Date	2013-01-23
NDC Exclude Flag	N

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.

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

ZYNCOF

dextromethorphan hbr and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52083-400
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (GRAPE)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52083-400-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2011
2	NDC:52083-400-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2011
3	NDC:52083-400-16	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/01/2011

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

Search by Drug Name or NDC

NDC 52083-0400-16 ZYNCOF 20; 400 mg/5mL; mg/5mL Details

ZYNCOF 20; 400 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 52083-0400-16 (52083040016)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cffd6d5f-0cb2-4d38-bdb0-6a21120418cc Details

Active ingredients (in each 5 mL tsp)

Purpose

Uses

Warnings

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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