Tukol®

Tukol®
SPL v1
SPL
SPL Set ID 57ab72e4-75f9-4044-bdc7-d515fdcc0116
Route
ORAL
Published
Effective Date 2023-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water

Identifiers & Packaging

Pill Appearance
Imprint: 603 Shape: oval Color: green Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-01-10

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental 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.

Section 53414-9

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

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • take only as directed (see Warnings)
  • do not exceed 4 doses per 24 hours

    Adults and children 12 years and over: take 2 softgels with water every 6 hours

    Children 4 to under 12 years: Ask a doctor

    Children under 4 years: Do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing
Do Not Use
  • with any other products 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 drugs. 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 sleep
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

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information
  • store at room temperature 20-25°C (68-77°F)
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

FD&C Blue #1, D&C Yellow #10, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Questions Or Comments?

Call toll free 1-877-994-3666

Weekdays from 8 am to 6 pm

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts
  • a skin reaction occurs. 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 enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 24 Softgel Blister Pack Carton

NEW

Tukol®

NIGHT TIME

COLD AND FLU RELIEF

Acetaminophen / Dextromethorphan HBr /

Doxylamine succinate

  • COUGH
  • RUNNY NOSE
  • SORE THROAT
  • ACHES
  • NASAL CONGESTION
  • FEVER

24

Softgels


Structured Label Content

Uses

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental 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.

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 softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • take only as directed (see Warnings)
  • do not exceed 4 doses per 24 hours

    Adults and children 12 years and over: take 2 softgels with water every 6 hours

    Children 4 to under 12 years: Ask a doctor

    Children under 4 years: Do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing
Do Not Use (Do not use)
  • with any other products 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 drugs. 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 sleep
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)

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information (Other information)
  • store at room temperature 20-25°C (68-77°F)
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

FD&C Blue #1, D&C Yellow #10, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-994-3666

Weekdays from 8 am to 6 pm

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • 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)
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts
  • a skin reaction occurs. 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 enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 24 Softgel Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton)

NEW

Tukol®

NIGHT TIME

COLD AND FLU RELIEF

Acetaminophen / Dextromethorphan HBr /

Doxylamine succinate

  • COUGH
  • RUNNY NOSE
  • SORE THROAT
  • ACHES
  • NASAL CONGESTION
  • FEVER

24

Softgels


Advanced Ingredient Data


Raw Label Data

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