TUKOL COUGH AND CONGESTION- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Tukol Cough and Congestion by

Drug Labeling and Warnings

Tukol Cough and Congestion by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each 5 mL tsp)

Dextromethorphan HBr, 10 mg
Guaifenesin, 100 mg
Phenylephrine HCl, 5 mg

Purpose

Cough Suppressant
Expectorant
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 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.

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.

Do not exceed recommended dosage.

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

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: dose
• adults and children 12 years and over: 2 teaspoons (10 ml) every 4 hours
• children under 12: do not use

Other information

• each 10 mL contains: sodium 6 mg

• store at 20-25°C (68-77°F). Do not refrigerate

• dosage cup provided

Inactive ingredients

Citric acid, FD & C Red 40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1 877 99 GENOM (43666)

Distributed by:
Genomma Lab USA Inc.,
Houston, TX, 77027

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle Label)

EXPECTORANT/COUGH SUPPRESSANT/NASAL DECONGESTANT
Guaifenesin / Dextromethorphan HBr / Phenylephrine HCI

Tukol®

COUGH & CONGESTION
 

• Quiets Cough

• Thins and loosens phlegm

• Clears Nasal Congestion

Ages 12+   4 FL OZ (118 ml)

   

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Carton Label)

EXPECTORANT/COUGH SUPPRESSANT/NASAL DECONGESTANT
Guaifenesin / Dextromethorphan HBr / Phenylephrine HCI

Tukol®

COUGH & CONGESTION
 

• Quiets Cough

• Thins and loosens phlegm

• Clears Nasal Congestion

Ages 12+   4 FL OZ (118 ml)

   

INGREDIENTS AND APPEARANCE

TUKOL COUGH AND CONGESTION 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-918
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENTHOL (UNII: BZ1R15MTK7)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (a clear red colored liquid)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-918-24	1 in 1 CARTON	11/14/2017
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/14/2017

Labeler - Genomma Lab USA Inc (832323534)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(50066-918)