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Tukol A

Medically reviewed on December 28, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 50mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Genomma Lab USA, Inc.
NDC Code: 50066-536

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 A 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-536
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50066-536-24118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/09/2014
Labeler - Genomma Lab USA, Inc. (832323534)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(50066-536)

 
Genomma Lab USA, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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