TUKOL A- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Tukol A by

Drug Labeling and Warnings

Tukol A by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc., AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TUKOL A 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-536
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (GRAPE FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-536-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/09/2014

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-536)