TUKOL CHILDREN COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup 
Genomma Lab USA

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Tukol ® Children's Cough & Congestion Syrup

Drug Facts

 Active Ingredient (in each 5 mL or 1 teaspoon) Purpose
 Dextromethorphan HBr, 5 mg Cough Suppressant
 Guaifenesin, 50 mg Expectorant
 Phenylephrine HCl, 2.5 mg Nasal Decongestant                            

Uses

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.

Do not exceed recommended dosage.

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 lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant 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.

Directions

agedose
children 6 to under 12 years

2 teaspoons (10 mL) every 4 hours

children 4 to under 6 years

1 teaspoon (5 mL) every 4 hours

children under 4 years

do not use

Other information

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?

1-877-994-3666

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Principal Display Panel - 118 ml Bottle Carton

Tukol ®

Children's

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages
4+

Relieves:

4 FL OZ (118 ml)

TUKOL CHILDREN COUGH AND CONGESTION 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-308-041 in 1 CARTON06/01/2022
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2022
Labeler - Genomma Lab USA (832323534)
Registrant - Genomma Lab USA (832323534)

Revised: 10/2024
Document Id: 2439cdd1-e22d-530e-e063-6394a90ab78e
Set id: 235a6d2b-7302-410c-be35-4d5ff7bbdfce
Version: 6
Effective Time: 20241011
 
Genomma Lab USA