FDA.reportPublic FDA data

Tukol Sugar Free Cough and Cold

Manufacturer
Genomma Lab USA
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:23:47

Label at a glance#

ProductTukol Sugar Free Cough and Cold
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 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, this adult strength product is not intended for use in children under 12 years of age, measure only with dosing cup provided, keep dosing cup with product, TSP = teaspoon mL = milliliter dose as follows: age dose adults and children 12 years and over 10 mL (2 teaspoons) every 4 hours children under 12 years do not use

Storage and handling

store at 15-30°C (59-86°F). Do not refrigerate, alcohol-frees, see bottom panel for lot number and expiration date.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL)Purposes
Dextromethorphan HBr, 20 mgCough Suppressant
Guaifenesin, 200 mgExpectorant

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

OTC - DO NOT USE SECTION

Do not useif 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

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus),
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough 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

Do not exceed recommended dosage.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24 hour period,
  • this adult strength product is not intended for use in children under 12 years of age,
  • measure only with dosing cup provided,
  • keep dosing cup with product,
  • TSP = teaspoon
  • mL = milliliter
  • dose as follows:
agedose
adults and children 12 years and over10 mL (2 teaspoons) every 4 hours
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at 15-30°C (59-86°F). Do not refrigerate,
  • alcohol-frees,
  • see bottom panel for lot number and expiration date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-877-994-3666Monday to Friday from 8 am to 6 pm, Central Time.

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextromethorphan HBr / Guaifenesin

Tukol ®

SUGAR FREE
0%

COUGH & COLD

Ages
12+

HBP
HIGH BLOOD PRESSURE

RELIEVES COUGH

RELIEVES CHEST CONGESTION

SUGAR-FREE FORMULA
FOR DIABETICS

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-505-04Tukol Sugar Free Cough and Cold1 in 1 CARTONSYRUP13
50066-505-04Tukol Sugar Free Cough and Cold118 mL in 1 BOTTLE, PLASTICSYRUP1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-505TUKOL SUGAR FREE COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SYRUP [GENOMMA LAB USA]3Current NDC, 2 package rows20241010_95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-50550066-505-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

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
Tukol Sugar Free Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINGenomma Lab USA95e0a3eb-5a58-4c8b-a70b-fb0cca1e08412024-10-08WarningsExact identifier
ndc (package): 50066-505-04
ndc (product): 50066-505
ndc11 (package): 50066050504
spl id: 23f8271b-e6f1-8897-e063-6394a90a9c82
spl set id: 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841

Reported adverse events (FAERS/openFDA)#

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