FDA.reportPublic FDA data

Tukol Honey Daytime Cold and Flu

Manufacturer
Genomma Lab USA
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:28:05

Label at a glance#

ProductTukol Honey Daytime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not take mare than directed do not take more than 4 doses in any 24 hours this adult strength product is not inteded for use in children under 12 years of age measyre only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows age dose adults and children 12 years of age and over 30 mL (2 tablespoons) every 4 hours Children under 12 years Do not use When using Day...

Storage and handling

each 30 mL contains sodium: 18 mg store between 15-30 o C (59-86 o F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves cold/flu symptoms:

  • minor aches and pain
  • headache
  • sore throat
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

The product contains Acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash.

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • 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 two 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

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

  • if you are taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.
  • new symptoms occur
  • 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.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take mare than directed
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not inteded for use in children under 12 years of age
  • measyre only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
  • TBSP = tablespoon
  • dose as follows
agedose
adults and children 12 years of age and over30 mL (2 tablespoons) every 4 hours
Children under 12 yearsDo not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains sodium: 18 mg
  • store between 15-30 oC (59-86 oF)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-877-994-3666 Monday 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

Principal Display Panel - 118 ml Bottle CartonPrincipal Display Panel - 118 ml Bottle Carton

Day Time

Tukol ®

HONEY MULTI SYMPTOM

COLD & FLU

Acetaminophen / Dextromethorphan HBr
/ Phenylephrine HCl

Ages
12+

NATURAL
HONEY
FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • NASAL CONGESTION AND COUGH

4 FL OZ (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN8
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD8
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY8
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY8
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-302-042024-01-11C16284748780-10191ceaa-70af-198a-e063-dbdaa90aec3eTukol ® Honey Daytime Cold & Flu
50066-302-042023-07-28C16284748780-10191ceaa-70af-198a-e063-dbdaa90aec3eTukol ® Honey Daytime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-302-04Tukol Honey Daytime Cold and Flu1 in 1 CARTONSYRUP18
50066-302-04Tukol Honey Daytime Cold and Flu118 mL in 1 BOTTLE, PLASTICSYRUP1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-302TUKOL HONEY DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]8Current NDC, Legacy NDC, 2 package rows20241023_c9572b16-8e28-4f98-bd87-8a07721a49c6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-30250066-302-04

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HONEYY9H1V576FHIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Honey Daytime and Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbccc11d2-d227-4cbb-b0fc-ac6abb6dce572024-10-22WarningsExact identifier
ndc (package): 50066-302-04
ndc11 (package): 50066030204
Tukol Honey Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAc9572b16-8e28-4f98-bd87-8a07721a49c62024-10-21WarningsExact identifier
ndc (package): 50066-302-04
ndc (product): 50066-302
ndc11 (package): 50066030204
spl id: 24fd90bc-bb83-4862-e063-6394a90a54c6
spl set id: c9572b16-8e28-4f98-bd87-8a07721a49c6

Reported adverse events (FAERS/openFDA)#

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