Tukol Max Action Cold, Sore Throat & Cough - 516

Tukol Max Action Cold, Sore Throat & Cough - 516
SPL v8
SPL
SPL Set ID c8eebe64-00bf-436d-a9fc-1623401bebfa
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-16
Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

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

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
Warnings

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.

Directions
  • 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

Do Not Use
  • 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.
Drug Facts

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

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

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?

1-877-994-3666

Monday to Friday from 8 am to 6 pm, Central time

When Using This Product

When using this product do not use more than directed

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 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

as a health professional before use

Keep Out of Reach of Children

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.

Ask A Doctor Before Use If You Have
  • 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

You are taking the blood thinning drug warfarin

Tukol Max Action Cold, Flu and Sore Throat

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

Structured Label Content

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
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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.

Directions
  • 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

Do Not Use (Do not use)
  • 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.
Drug Facts

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

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

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? (Questions or comments?)

1-877-994-3666

Monday to Friday from 8 am to 6 pm, Central time

When Using This Product (When using this product)

When using this product do not use more than directed

Stop Use and Ask A Doctor If (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 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 (If pregnant or breast-feeding)

as a health professional before use

Keep Out of Reach of Children (Keep out of reach of children)

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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 (Ask a doctor or pharmacist before use if)

You are taking the blood thinning drug warfarin

Tukol Max Action Cold, Flu and Sore Throat (Tukol MAX ACTION Cold, Flu and Sore Throat)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:51.022462 · Updated: 2026-03-14T23:04:09.079304