Tukol® Cough & Cold Honey Flavor Syrup

Tukol® Cough & Cold Honey Flavor Syrup
SPL v52
SPL
SPL Set ID a4b333dc-58da-45db-87b6-6fcb8fb542b8
Route
ORAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Honey Sucralose Xanthan Gum Sorbitol Solution Fd&c Yellow No. 6 Glycerin Propylene Glycol Sodium Benzoate Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-20

Description

Active ingredients (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr,10 mg..................................Cough Suppressant Guaifenesin, 100 mg.................................................Expectorant Phenylephrine HCl, 5 mg..........................................Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Do not use 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.

Indications and Usage

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
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24 hour period
  • 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
  • TSP = teaspoon
age dose
adults and children 12 years and over 2 teaspoons (10 mL) every 4 hours
children under 12 years do not use

Description

Active ingredients (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr,10 mg..................................Cough Suppressant Guaifenesin, 100 mg.................................................Expectorant Phenylephrine HCl, 5 mg..........................................Nasal Decongestant

Section 44425-7

Other information

  • each teaspoon (5 mL) contains: sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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.
Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant

Do not exceed recommended dosage

Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active ingredients (in each 5 mL or 1 teaspoon) Purpose

Dextromethorphan HBr,10 mg..................................Cough Suppressant

Guaifenesin, 100 mg.................................................Expectorant

Phenylephrine HCl, 5 mg..........................................Nasal Decongestant


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24 hour period
  • 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
  • TSP = teaspoon
age dose
adults and children 12 years and over 2 teaspoons (10 mL) every 4 hours
children under 12 years do not use

Warnings and Precautions (34071-1)

Warnings

Do not use 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.

Section 44425-7 (44425-7)

Other information

  • each teaspoon (5 mL) contains: sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant

Do not exceed recommended dosage

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL or 1 teaspoon) Purpose

Dextromethorphan HBr,10 mg..................................Cough Suppressant

Guaifenesin, 100 mg.................................................Expectorant

Phenylephrine HCl, 5 mg..........................................Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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