TUKOL MAX ACTION COLD SORE THROAT AND COUGH

Manufacturer
Genomma Lab USA Inc | Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:00

Label at a glance#

ProductTUKOL MAX ACTION COLD SORE THROAT AND COUGH
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 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 loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

Do not take more than directed Do not take more than 6 doses in 24 hours This adult strength product is not intended for use in children under 12 years of age Dose as follows or as directed by a doctor Use dose cup provided 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 12 mg Store at 20-25°C (68-77°F), do not refrigerate

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL)

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

Purposes

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 loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION


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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 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 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

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a 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

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • cough comes back or occurs with fever, rash, or headache that lasts
  • 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

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN 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

  • Do not take more than directed
  • Do not take more than 6 doses in 24 hours
  • This adult strength product is not intended for use in children under 12 years of age
  • Dose as follows or as directed by a doctor
  • Use dose cup provided

age
dose
adults and children 12 years and older
20 mL every 4 hours
children under 12 years of age
do not use

Other information

STORAGE AND HANDLING SECTION

  • Each 20 mL contains: sodium 12 mg
  • Store at 20-25°C (68-77°F), do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1 877 99 GENOM (43666) Monday to Friday from 8 AM to 6 PM, Central time. 

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

Tukol®

MAX ACTION


COLD, SORE THROAT & COUGH


  • Fever & Headache
  • Clears Nasal Congestion
  • Thins & Loosens Mucus
  • Controls Cough 

Ages 12+     6 FL OZ (177 ml)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle) - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

Tukol®

MAX ACTION


COLD, SORE THROAT & COUGH


  • Fever & Headache
  • Clears Nasal Congestion
  • Thins & Loosens Mucus
  • Controls Cough

Ages 12+     6 FL OZ (177 ml)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (177 mL Bottle) - CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (177 mL Bottle) - Carton

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
50066-91650066-916-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
5e0bbc4c-6145-4e44-abcf-c369482a69dde78ea36b-1e58-48c7-b6f3-7c102ecb0bc82020-11-26WarningsExact identifier
spl id: 5e0bbc4c-6145-4e44-abcf-c369482a69dd
spl set id: e78ea36b-1e58-48c7-b6f3-7c102ecb0bc8

Reported adverse events (FAERS/openFDA)#

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