Tukol MAX ACTION Cold, Sore Throat and Cough

Manufacturer
Genomma Lab USA, Inc
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:26:26

Label at a glance#

ProductTukol MAX ACTION Cold, Sore Throat and Cough
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains sore throat headache temporarily reduces fever helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Dosage and administration

do not take more than directed Do not take more than 4 doses in any 24 hours 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 mL = mililiter dose as follows  age  dose  adults and children 12 years of age and older  20 mL every 4 hours  children under 12 years of age  do not use

Label contents#

Full prescribing information#

Drug Facts Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash.

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

Sore throat warning:If sore throat is severe, persists 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, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

You are taking the blood thinning drug warfarin

When using this product

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

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough comes back or occurs with fever, rash or persistant headache
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

as a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: 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 even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • Do not take more than 4 doses in any 24 hours
  • 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
  • mL = mililiter
  • dose as follows
 age dose
 adults and children 12 years of age and older 20 mL every 4 hours
 children under 12 years of age do not use

Other information

OTHER SAFETY INFORMATION

  • Each 20 mL contains: sodium 10 mg
  • store between15-30°C (59-86 °F), do not refrigerate

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

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

Tukol MAX ACTION Cold, Flu and Sore Throat

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tukol Max ColdTukol Max Cold

Tukol® MAX ACTION


DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING


ACETAMINOPHEN/Dextromethorphan HBr/Guaifenesin/Phenylephrine HCl

Relieves

  • Minor aches and Pain
  • Fever
  • Nasal & Chest Congestion
  • Cough

Ages 12+
6 FL OZ (177 mL)

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN8
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD8
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY8
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY8
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY8

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-516-25Tukol MAX ACTION Cold, Sore Throat and Cough177 mL in 1 BOTTLELIQUID1778

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-516TUKOL MAX ACTION COLD, SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]8Current NDC, Legacy NDC, 1 package rows20241018_c8eebe64-00bf-436d-a9fc-1623401bebfa.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-51650066-516-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
ndc (package): 50066-516-25
ndc (product): 50066-516
ndc11 (package): 50066051625
spl id: 249cf9d5-787c-0364-e063-6394a90a6e67
spl set id: c8eebe64-00bf-436d-a9fc-1623401bebfa

Reported adverse events (FAERS/openFDA)#

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