SPL v4
SPL
SPL Set ID 651f0d7c-c76b-434d-95fd-427609b40b46
Route
ORAL
Published
Effective Date 2017-12-28
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 Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-09

Description

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


Medication Information

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

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

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.

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

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

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)

When Using This Product
  • do not use more than directed
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

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.



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

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.

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.


Structured Label Content

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
Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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.

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

Active Ingredients (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

Inactive Ingredients (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? (Questions or comments?)

1 877 99 GENOM (43666)

When Using This Product (When using this product)
  • do not use more than directed
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

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 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.



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

Keep Out of Reach of Children (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.

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)

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking any other oral nasal decongestant or stimulant.


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