FDA.reportPublic FDA data

G-ZYNCOF

Manufacturer
Kramer Novis
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:24

Label at a glance#

ProductG-ZYNCOF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and 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

Dosage and administration

• do not take more than 6 doses in any 24-hour period. • mL = milliliter  age   dose  Adults and children 12 years of age and over  1 teaspoon (5 mL) every 4 hours  Children under 12 years of age  do not use

Storage and handling

•  Tamper evident feature: Do not use if printed security seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL, 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

• 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.

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.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

​Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than 6 doses in any 24-hour period. • mL = milliliter

 age  dose
 Adults and children 12 years of age and over 1 teaspoon (5 mL) every 4 hours
 Children under 12 years of age do not use

Other information

STORAGE AND HANDLING SECTION

• Tamper evident feature: Do not use if printed security seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-787-767-2072 
You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

SPL UNCLASSIFIED SECTION

Dextromethorphan HBr
COUGH SUPPRESSANT

Guaifenesin
EXPECTORANT

SUGAR FREE & ALCOHOL FREE

NO DYE - NO SACCHARIN - NO ASPARTAME

KramerNovis
Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis, San Juan, PR 00917

www.kramernovis.com

RECENT MAJOR CHANGES SECTION

Directions: (The following changes were made)

• mL=milliliter
• A table was included with the dosage instructions according to age:

agedose
Adults and children 12 years of age and over1 teaspoon (5 mL) every 4 hours
Children under 12 years of agedo not use

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G-ZYNCOFG-ZYNCOF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1113368dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSN5
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCD5
1113368dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSY5
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130352083600166GTIN-13: 0352083600166
EAN-13: 0352083600166
GTIN-12: 352083600166
UPC-A: 352083600166
GTIN storage (14 digits): 00352083600166		52083600-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-600-16G-ZYNCOF473 mL in 1 BOTTLE, PLASTICSYRUP4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-600-16ML - Milliliter52083-600edeaf9ed-dd8b-4828-abfe-35d4869c739412013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L41
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-60052083-600-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SOLUTION / ORAL6108 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4CAPSULE, EXTENDED RELEASE / ORAL91 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET / ORAL0.6 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET / ORAL0.6 mgExact identifier — unii+route
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, FILM COATED / ORAL0.13 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUSPENSION / ORAL4000 mgExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SOLUTION / ORAL6108 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUSPENSION / ORAL4000 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, FILM COATED / ORAL0.13 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4CAPSULE, EXTENDED RELEASE / ORAL91 mgExact identifier — unii+route
12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
ndc (package): 52083-600-16
ndc (product): 52083-600
ndc11 (package): 52083060016
spl id: a7c507ab-f326-4890-b26d-d80c59cacf8a
spl set id: c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.