Tukol ®

Tukol ®
SPL v9
SPL
SPL Set ID bf25f38e-3549-4f78-be90-46605b5f2c11
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 (1 mg) Doxylamine (0.4167 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Honey Water Glycerin Propylene Glycol Sorbitol Sodium Benzoate Sucralose

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 these common cold and flu symptoms:

  • sore throat
  • headache
  • minor aches and pain
  • runny nose and sneezing
  • 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 30 mg Cough suppressant
Doxylamine Succinate 12.5 mg Antihistamine
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
  • TBSP = tablespoon
  • dose as follows
age dose
adults and children 12 years of age and over 30 mL (2 Tablespoons) every 6 hours
Children under 12 years of age do not use

when using day time and night time prodcuts, 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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor.
  • 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.
  • to make a child sleepy
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) 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 may cause serious health problems. 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 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 8 am to 6 pm, Central Time

When Using This Product
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • 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 headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use
  • if you are taking sedatives or tranquillizers
  • if you are taking the blood thinning drug warfarin
Principal Display Panel 118 Ml Bottle Carton

Night Time

Tukol ®

HONEY MULTISYMPTOM

COLD & FLU

Acetaminophen/ Dextromethorphan HBr /

Doxylamine succinate

Ages

12+

NATURAL

HONEY

FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • SNEEZING, RUNNY NOSE
  • COUGH

4 FL OZ (118 ml)


Structured Label Content

Uses

Temporarily relieves these common cold and flu symptoms:

  • sore throat
  • headache
  • minor aches and pain
  • runny nose and sneezing
  • 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 30 mg Cough suppressant
Doxylamine Succinate 12.5 mg Antihistamine
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
  • TBSP = tablespoon
  • dose as follows
age dose
adults and children 12 years of age and over 30 mL (2 Tablespoons) every 6 hours
Children under 12 years of age do not use

when using day time and night time prodcuts, 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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor.
  • 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.
  • to make a child sleepy
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) 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 may cause serious health problems. 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 (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 8 am to 6 pm, Central Time

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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 headache that lasts. 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • if you are taking sedatives or tranquillizers
  • if you are taking the blood thinning drug warfarin
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

Night Time

Tukol ®

HONEY MULTISYMPTOM

COLD & FLU

Acetaminophen/ Dextromethorphan HBr /

Doxylamine succinate

Ages

12+

NATURAL

HONEY

FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • SNEEZING, RUNNY NOSE
  • COUGH

4 FL OZ (118 ml)


Advanced Ingredient Data


Raw Label Data

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