Tukol ®

Tukol ®
SPL v6
SPL
SPL Set ID 235a6d2b-7302-410c-be35-4d5ff7bbdfce
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
Section 50568-5

Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.

Section 50569-3

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 55105-1
 Active Ingredient (in each 5 mL or 1 teaspoon)  Purpose
 Dextromethorphan HBr, 5 mg  Cough Suppressant
 Guaifenesin, 50 mg  Expectorant
 Phenylephrine HCl, 2.5 mg  Nasal Decongestant                            

Directions
  • Do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP = teaspoon
age dose
children 6 to under 12 years

2 teaspoons (10 mL) every 4 hours

children 4 to under 6 years

1 teaspoon (5 mL) every 4 hours

children under 4 years

do not use

Other Information
  • each teaspoon (5 mL) contains:sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate.
Inactive Ingredients

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

Principal Display Panel 118 Ml Bottle Carton

Tukol ®

Children's

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages

4+

Relieves:

  • COUGH
  • NASAL CONGESTION
  • CHEST CONGESTION

4 FL OZ (118 ml)


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 55105-1 (55105-1)
 Active Ingredient (in each 5 mL or 1 teaspoon)  Purpose
 Dextromethorphan HBr, 5 mg  Cough Suppressant
 Guaifenesin, 50 mg  Expectorant
 Phenylephrine HCl, 2.5 mg  Nasal Decongestant                            

Directions
  • Do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP = teaspoon
age dose
children 6 to under 12 years

2 teaspoons (10 mL) every 4 hours

children 4 to under 6 years

1 teaspoon (5 mL) every 4 hours

children under 4 years

do not use

Other Information (Other information)
  • each teaspoon (5 mL) contains:sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-877-994-3666

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

Tukol ®

Children's

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages

4+

Relieves:

  • COUGH
  • NASAL CONGESTION
  • CHEST CONGESTION

4 FL OZ (118 ml)


Advanced Ingredient Data


Raw Label Data

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