TUKOL MAX ACTION SINUS LIQUID- acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup 
Genomma Lab USA

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.

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Tukol® Max Action Sinus Liquid

Drug Facts

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650mgPain reliever
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

Uses

temporarily relieves:

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters, rash.

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • for children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or 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 you are taking the blood thinning drug warfarin.

When using this product do not use more than directed

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

AgeDose
Adults and children 12 years and older20 mL every 4 hours
Children under 12 years of ageDo not use

Other information

Inactive ingredients

Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666

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

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

NEW

Tukol®

MAX ACTION

SINUS

Headache and Congestion

Acetaminophen / Guaifenesin / Phenylephrine HCl

For Ages
12 & Over

NATURAL
GINGER FLAVOR

SINUS CONGESTION
HEADACHE
EXPECTORANT

6 FL OZ (177 ml)

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
TUKOL MAX ACTION SINUS LIQUID 
acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-305
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen32.5 mg  in 1 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin20 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Sodium benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (Amber to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-305-061 in 1 CARTON07/30/2021
1177 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 FINALpart34107/30/2021
Labeler - Genomma Lab USA (832323534)

Revised: 8/2021
Document Id: 6cfd6ddd-7bd8-47d7-8ac0-c300e542c0a0
Set id: e7897198-c917-4937-9f56-e63eab73c9d6
Version: 1
Effective Time: 20210803
 
Genomma Lab USA