Tukol® - DailyMed Details

Tukol®

SPL v1

SPL

SPL Set ID e7897198-c917-4937-9f56-e63eab73c9d6

Route

ORAL

Published

Effective Date 2021-08-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (32.5 mg) Guaifenesin (20 mg) Phenylephrine (0.5 mg)

Inactive Ingredients

Water Glycerin Propylene Glycol Sorbitol Sodium Benzoate Sucralose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH FINAL Active Since 2021-07-30

Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not use more than directed

Section 50568-5

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

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Directions

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

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, 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

Questions?

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

Allergy Alert

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.

Liver Warning

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

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 for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

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

Inactive Ingredients

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

Stop Use and Ask A Doctor If

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.

Ask A Doctor Before Use If You Have

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)

Principal Display Panel 177 Ml Bottle Carton

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)

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Directions

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

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, 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

Questions?

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

Allergy Alert (Allergy alert)

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.

Liver Warning (Liver warning)

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

Overdose Warning (Overdose warning)

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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.

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

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)

Principal Display Panel 177 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton)

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)

Advanced Ingredient Data

[{"name": "Acetaminophen", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "32.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Guaifenesin", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sucralose", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not use more than directed", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 20 mL) Purposes Acetaminophen 650mg Pain reliever Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant", "Directions": "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", "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, 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", "Questions?": "Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666", "Allergy alert": "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.", "Liver warning": "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", "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 for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "each 20 mL contains: sodium 10 mg dosage cup provided store between 15-30°C (59-86°F) do not refrigerate", "Inactive ingredients": "Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum", "Stop use and ask a doctor if": "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.", "Ask a doctor before use if you have": "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)", "PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton": "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.954761 · Updated: 2026-03-14T22:59:44.713365