Tukol ®

Tukol ®
SPL v6
SPL
SPL Set ID dae33df8-2294-4242-a25b-2d89d1f63b23
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 Yellow No. 6 Honey Sodium Benzoate Water Glycerin Propylene Glycol Sorbitol Xanthan Gum 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
  • 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 50567-7

Do not exceed recommended dosage.

Section 50568-5

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

Section 50570-1

Do not use in a childwho 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 ingredients (in each 2.5 mL) Purpose
Dextromethorphan HBr, 5 mg Cough suppressant
Guaifenesin, 50 mg Expectorant
Phenylephrine HCl, 2.5 mg Nasal decongestant

Directions
  • do not exceed 6 doses in a 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
age dose
children 6 to under 12 years 5 mL every 4 hours
children 4 to under 6 years 2.5 mL every 4 hours
children under 4 years do not use

Other Information
  • each 2.5 mL contains: sodium 1 mg
  • store at 15-30ºC (59-86ºF). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

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 persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If the Child Has
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 118 Ml Bottle Carton

Tukol ®

HONEY CHILDREN

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages

4+

NATURAL

HONEY

FLAVOR

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 50567-7 (50567-7)

Do not exceed recommended dosage.

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use in a childwho 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 ingredients (in each 2.5 mL) Purpose
Dextromethorphan HBr, 5 mg Cough suppressant
Guaifenesin, 50 mg Expectorant
Phenylephrine HCl, 2.5 mg Nasal decongestant

Directions
  • do not exceed 6 doses in a 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
age dose
children 6 to under 12 years 5 mL every 4 hours
children 4 to under 6 years 2.5 mL every 4 hours
children under 4 years do not use

Other Information (Other information)
  • each 2.5 mL contains: sodium 1 mg
  • store at 15-30ºC (59-86ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-877-994-3666

Stop Use and Ask A Doctor If (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 persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

Tukol ®

HONEY CHILDREN

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages

4+

NATURAL

HONEY

FLAVOR

Relieves:

  • COUGH
  • NASAL CONGESTION
  • CHEST CONGESTION

4 FL OZ (118 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)