SPL v6
SPL
SPL Set ID aef2ad43-145d-4abc-bccc-2c5fdd6882f9
Route
ORAL
Published
Effective Date 2019-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-05-15

Description

DRUG FACTS Active ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 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 tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 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
Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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.

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



Age - adults and children 12 years and over    Dose - 2 teaspoons every 4 hours



Age - children under 12    Dose - do not use

Other Information
  • each teaspoon contains: sodium 3 mg
  • store at 20‐25 ° C (68‐77 ° F). Do not refrigerate.
  • dosage cup provided
Active Ingredients

DRUG FACTS





Active ingredients

(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

Inactive Ingredients

anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

1 877 99 GENOM (43666)

Product Label Tukol 504 Dpl

Tukol®

DO NOT USE IF PRINTED SEAL UNDER CAP

IS TORN OR MISSING

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Expectorant/Cough Suppressant/Nasal Decongestant

Tukol®

Cough & Congestion

  • Quiets Cough
  • Thins and loosens phlegm
  • Clears Nasal Congestion

Ages/ 12+    4 FL OZ (118 mL)

2000005853

6  50066 00012  6

LOT No.

Exp.

Distributed by

Genomma Lab USA Inc.

Houston, TX 77027

BX-006  Rev. 03

Genoma Lab.®

rege

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.

If Pregnant Or Breast Feeding

ask a health professional before use.

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 right away.

Ask A Doctor Before Use Ask A Doctor Or Pharmacist Before Use

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







Ask a doctor or pharmacist before use if you are



taking any other oral nasal decongestant or stimulant.



When using this product do not use more than directed.


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
Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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.

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



Age - adults and children 12 years and over    Dose - 2 teaspoons every 4 hours



Age - children under 12    Dose - do not use

Other Information (Other information)
  • each teaspoon contains: sodium 3 mg
  • store at 20‐25 ° C (68‐77 ° F). Do not refrigerate.
  • dosage cup provided
Active Ingredients (Active ingredients)

DRUG FACTS





Active ingredients

(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

1 877 99 GENOM (43666)

Product Label Tukol 504 Dpl (Product Label Tukol 504 DPL)

Tukol®

DO NOT USE IF PRINTED SEAL UNDER CAP

IS TORN OR MISSING

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Expectorant/Cough Suppressant/Nasal Decongestant

Tukol®

Cough & Congestion

  • Quiets Cough
  • Thins and loosens phlegm
  • Clears Nasal Congestion

Ages/ 12+    4 FL OZ (118 mL)

2000005853

6  50066 00012  6

LOT No.

Exp.

Distributed by

Genomma Lab USA Inc.

Houston, TX 77027

BX-006  Rev. 03

Genoma Lab.®

rege

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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 right away.

Ask A Doctor Before Use Ask A Doctor Or Pharmacist Before Use (Ask a doctor before use Ask a doctor or pharmacist before use)

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







Ask a doctor or pharmacist before use if you are



taking any other oral nasal decongestant or stimulant.



When using this product do not use more than directed.


Advanced Ingredient Data


Raw Label Data

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