FDA.reportPublic FDA data

Tukol Max Action Sinus Liquid

Manufacturer
Genomma Lab USA
Effective date
2021-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:48

Label at a glance#

ProductTukol Max Action Sinus Liquid
Active ingredientAcetaminophen, Guaifenesin, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure temporarily promotes nasal and sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

take only as recommended (see Overdose warning ) use dosage cup mL = milliliter do not take more than 6 doses in any 24-hour period Age Dose Adults and children 12 years and older 20 mL every 4 hours Children under 12 years of age Do not use

Storage and handling

each 20 mL contains: sodium 10 mg dosage cup provided store between 15-30°C (59-86°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 20 mL)Purposes
Acetaminophen 650mgPain reliever
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • nasal congestion
  • headache
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily promotes nasal and sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses 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 a skin reaction occurs, stop use and seek medical help right away.

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 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.
  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with 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.

Overdose warning

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as recommended (see Overdose warning)
  • use dosage cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period
AgeDose
Adults and children 12 years and older20 mL every 4 hours
Children under 12 years of ageDo not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30°C (59-86°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Tukol®

MAX ACTION

SINUS

Headache and Congestion

Acetaminophen / Guaifenesin / Phenylephrine HCl

For Ages
12 & Over

NATURAL
GINGER FLAVOR

  • SINUS CONGESTION
  • HEADACHE
  • EXPECTORANT

6 FL OZ (177 ml)

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116568acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN1
1116568acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1116568acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY1
1116568acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1116568APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY1
1116568APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-305-062025-01-30C16284748780-12cef2736-8019-d83d-e063-dadaa90ab31fTukol ® Max Action Sinus Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-305-06Tukol Max Action Sinus Liquid177 mL in 1 BOTTLE, PLASTICSYRUP1771
50066-305-06Tukol Max Action Sinus Liquid1 in 1 CARTONSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-305TUKOL MAX ACTION SINUS LIQUID (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA]1Legacy NDC, 2 package rows20210806_e7897198-c917-4937-9f56-e63eab73c9d6.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
50066-30550066-305-06

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
Acetaminophen362O9ITL9DACTIB
Guaifenesin495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WATER059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Sorbitol506T60A25RIACT
Sodium benzoateOJ245FE5EUIACT
Sucralose96K6UQ3ZD4IACT

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
6cfd6ddd-7bd8-47d7-8ac0-c300e542c0a0e7897198-c917-4937-9f56-e63eab73c9d62021-08-03WarningsExact identifier
spl id: 6cfd6ddd-7bd8-47d7-8ac0-c300e542c0a0
spl set id: e7897198-c917-4937-9f56-e63eab73c9d6

Reported adverse events (FAERS/openFDA)#

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