Tukol® Cough & Cold Honey Flavor Syrup

Manufacturer
Genomma Lab USA
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
52
Source
full-release
Hydrated at
2026-06-01 00:37:12

Label at a glance#

ProductTukol Cough And Cold Honey Flavor
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Storage and handling

Other information each teaspoon (5 mL) contains: sodium 3 mg store at 15-30°C (59-86°F). Do not refrigerate

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL or 1 teaspoon) Purpose
Dextromethorphan HBr,10 mg..................................Cough Suppressant
Guaifenesin, 100 mg.................................................Expectorant
Phenylephrine HCl, 5 mg..........................................Nasal Decongestant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant

Do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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
age dose
adults and children 12 years and over 2 teaspoons (10 mL) every 4 hours
children under 12 yearsdo not use

STORAGE AND HANDLING SECTION

Other information

  • each teaspoon (5 mL) contains: sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tukol-01tukol-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN52
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD52
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY52
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY52

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-534-042024-01-11C16284748780-10191ceaa-7135-198a-e063-dbdaa90aec3eTukol® Cough & Cold Honey Flavor Syrup
50066-534-042023-07-28C16284748780-10191ceaa-7135-198a-e063-dbdaa90aec3eTukol® Cough & Cold Honey Flavor Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-534-04Tukol Cough And Cold Honey Flavor118 mL in 1 BOTTLE, PLASTICSYRUP11852
50066-534-04Tukol Cough And Cold Honey Flavor1 in 1 CARTONSYRUP152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-534TUKOL COUGH AND COLD HONEY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]52Current NDC, Legacy NDC, 2 package rows20241115_a4b333dc-58da-45db-87b6-6fcb8fb542b8.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-53450066-534-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 Cough And Cold Honey FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAa4b333dc-58da-45db-87b6-6fcb8fb542b82024-11-12WarningsExact identifier
ndc (package): 50066-534-04
ndc (product): 50066-534
ndc11 (package): 50066053404
spl id: 26bab552-32fa-e4e1-e063-6394a90acefd
spl set id: a4b333dc-58da-45db-87b6-6fcb8fb542b8

Reported adverse events (FAERS/openFDA)#

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