Tukol®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Honey Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-09-15

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.

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

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

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 50568-5

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.

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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

Inactive Ingredients

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

Questions Or Comments?

1 877 99 GENOM (43666)

Monday to Friday from 8 am to 6 pm, Central time.

Drug Factsactive Ingredients

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

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.

Tukol X Pecto Miel Cough & Cold Product Label

Tukol^®

X-PECTO MIEL

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

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Cough Suppressant / Expectorant / Nasal Decongestant

Tukol^®

X-PECTO MIEL

Cough & Cold

Quiets Cough
Thins & loosens Phlegm
Clears Nasal Congestion

NATURAL HONEY _FLAFOR

Ages / 12+ 4 FL OZ (118 ml)

2000006935

6 50066 00042 0

LOT no.

Exp.

Distributed by Genomma Lab USA Inc.

Houston TX, 77027

BX-035 Rev. 02

Genomma Lab.^®

rege

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

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 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 50568-5 (50568-5)

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.

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1 877 99 GENOM (43666)

Monday to Friday from 8 am to 6 pm, Central time.

Drug Factsactive Ingredients (DRUG FACTSActive ingredients)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCL, USP 5 mg

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.

Tukol X Pecto Miel Cough & Cold Product Label (Tukol X-PECTO MIEL Cough & Cold product label)

Tukol^®

X-PECTO MIEL

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

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Cough Suppressant / Expectorant / Nasal Decongestant

Tukol^®

X-PECTO MIEL

Cough & Cold

Quiets Cough
Thins & loosens Phlegm
Clears Nasal Congestion

NATURAL HONEY _FLAFOR

Ages / 12+ 4 FL OZ (118 ml)

2000006935

6 50066 00042 0

LOT no.

Exp.

Distributed by Genomma Lab USA Inc.

Houston TX, 77027

BX-035 Rev. 02

Genomma Lab.^®

rege

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "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. 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", "Purposes": "Cough Suppressant Expectorant Nasal Decongestant", "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", "Inactive ingredients": "anhydrous citric acid, FD and C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum", "Questions or comments?": "1 877 99 GENOM (43666) Monday to Friday from 8 am to 6 pm, Central time.", "DRUG FACTSActive ingredients": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 5 mg", "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.", "Tukol X-PECTO MIEL Cough & Cold product label": "Tukol ® X-PECTO MIEL DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL Cough Suppressant / Expectorant / Nasal Decongestant Tukol ® X-PECTO MIEL Cough & Cold Quiets Cough Thins & loosens Phlegm Clears Nasal Congestion NATURAL HONEY FLAFOR Ages / 12+ 4 FL OZ (118 ml) 2000006935 6 50066 00042 0 LOT no. Exp. Distributed by Genomma Lab USA Inc. Houston TX, 77027 BX-035 Rev. 02 Genomma Lab. ® rege"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information