Tukol A Liquid
FDA Label NDC 50066-536

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Tukol A (NDC 50066-536). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

DRUG FACTS


Active ingredients
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 50 mg
Phenylephrine HCL, USP 2.5 mg

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

  • help 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

Warnings

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.

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)

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking any other oral nasal decongestant or stimulant.

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by a 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.

Keep Out Of Reach Of Children

Keep out of reach of children.

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

Directions

age                                               dose

children 6 to 12 years                    2 tsp (10 mL) every 4 hours

children 4 to 6 years                     1 tsp (5 mL) every 4 hours

children under 4 years                  do not use

  • do not exceed 6 doses in a 24-hour period
  • use enclosed dosage cup
  • tsp = teaspoon, mL = milliliter

Other Information

  • each 5 mL contains: sodium 3 mg
  • store at room temperature

Inactive Ingredients

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1 877 99 GENOM (43666)

Children's Tukol Bottle Label

Children’s Tukol®

Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

Ages 4+

Cough and Cold

Gets rid of phlegm
Quiets Cough
Clears nasal congestion

Grape Flavor

4 FL OZ (118 ml)

Drug Facts

Active ingredients                                            Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant

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

Warnings

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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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)

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

When using this product
• do not use more than directed

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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Drug Facts (continued)

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

Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter

        age                                       dose
children 6 to 12 years             2 teaspoons (10 mL) every 4 hours
children 4 to 6 years               1 teaspoons (5 mL) every 4 hours
children under 4 years             do not use

Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature

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? 1-877-99 GENOM (43666)

Distributed by Genomma Lab USA., Houston, TX, 77027

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

LR-063 Rev. 2

PEEL HERE

Tukol-btl-037-rv2 (Tukol Btl 037 Rv2)

Tukol-btl-037-rv2 (Tukol Btl 037 Rv2)

Children's Tukol Box Label

Children’s Tukol®


Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

DO NOT USE IF PRINTED SEAL UNDER CAP
             IS TORN OR MISSING

Children’s Tukol®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI


Ages 4+

Cough and Cold

Gets rid of phlegm
Quiets Cough
Clears nasal congestion

Grape Flavor

4 FL OZ (118 ml)

LOT No.
Exp.

Drug Facts

Active ingredients                                               Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant

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

Warnings

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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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)

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

When using this product
• do not use more than directed

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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

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

Distributed by
Genomma Lab USA Inc.,
Houston, TX 77027
Genomma Lab.®

     3
66975-3
    8/17

Drug Facts (continued)

Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter

     age                                        dose
children 6 to 12 years         2 teaspoons (10 mL) every 4 hours
children 4 to 6 years           1 teaspoons (5 mL) every 4 hours
children under 4 years         do not use

Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature

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? 1-877-99 GENOM (43666)

BX-037 Rev. 02
2FTAP1MUEWW1B

Tukol-bx-037-rv2 (Tukol Bx 037 Rv2)

Tukol-bx-037-rv2 (Tukol Bx 037 Rv2)

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