Tukol ®

Tukol ®
SPL v8
SPL
SPL Set ID c9572b16-8e28-4f98-bd87-8a07721a49c6
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (21.667 mg) Dextromethorphan (0.667 mg) Phenylephrine (0.333 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Sodium Benzoate Sucralose Anhydrous Citric Acid Fd&c Yellow No. 6 Honey

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-09

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves cold/flu symptoms:

  • minor aches and pain
  • headache
  • sore throat
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active Ingredients (in each 30 mL) Purpose
Acetaminophen 650 mg Pain reliever/Fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal Decongestant

Directions
  • do not take mare than directed
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not inteded for use in children under 12 years of age
  • measyre only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
  • TBSP = tablespoon
  • dose as follows
age dose
adults and children 12 years of age and over 30 mL (2 tablespoons) every 4 hours
Children under 12 years Do not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
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 two 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.
Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash.

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

Liver Warning

The product contains Acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (30 mL each) 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Other Information
  • each 30 mL contains sodium: 18 mg
  • store between 15-30 oC (59-86 oF)
  • do not refrigerate
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.

Inactive Ingredients

Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

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

When Using This Product
Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.
  • new symptoms occur
  • These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use
  • if you are taking the blood thinning drug warfarin
Principal Display Panel 118 Ml Bottle Carton

Day Time

Tukol ®

HONEY MULTI SYMPTOM

COLD & FLU

Acetaminophen / Dextromethorphan HBr

/ Phenylephrine HCl

Ages

12+

NATURAL

HONEY

FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • NASAL CONGESTION AND COUGH

4 FL OZ (118 ml)


Structured Label Content

Uses

Temporarily relieves cold/flu symptoms:

  • minor aches and pain
  • headache
  • sore throat
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 30 mL) Purpose
Acetaminophen 650 mg Pain reliever/Fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal Decongestant

Directions
  • do not take mare than directed
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not inteded for use in children under 12 years of age
  • measyre only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
  • TBSP = tablespoon
  • dose as follows
age dose
adults and children 12 years of age and over 30 mL (2 tablespoons) every 4 hours
Children under 12 years Do not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
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 two 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.
Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash.

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

Liver Warning (Liver warning)

The product contains Acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (30 mL each) 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)

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

Other Information (Other information)
  • each 30 mL contains sodium: 18 mg
  • store between 15-30 oC (59-86 oF)
  • do not refrigerate
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.
  • new symptoms occur
  • 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
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • if you are taking the blood thinning drug warfarin
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

Day Time

Tukol ®

HONEY MULTI SYMPTOM

COLD & FLU

Acetaminophen / Dextromethorphan HBr

/ Phenylephrine HCl

Ages

12+

NATURAL

HONEY

FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • NASAL CONGESTION AND COUGH

4 FL OZ (118 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)