TUKOL MAX ACTION SINUS CAPLETS- acetaminophen, guaifenesin and phenylephrine hydrochloride tablet, coated 
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 Caplets

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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:

  • blisters
  • rash
  • skin reddening

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • liver disease
  • high blood pressure
  • 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 exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-877-994-3666 8 AM-6 PM ET, Monday-Friday

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

NEW

Tukol® MAX ACTION

SINUS
HEADACHE AND CONGESTION

Acetaminophen / Guaifenesin / Phenylephrine HCl
Pain Reliever / Expectorant / Nasal Decongestant

Actual Size

20 Caplets

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
TUKOL MAX ACTION SINUS CAPLETS 
acetaminophen, guaifenesin and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-306
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
crospovidone (UNII: 2S7830E561)  
magnesium stearate (UNII: 70097M6I30)  
maltodextrin (UNII: 7CVR7L4A2D)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
microcrystalline cellulose (UNII: OP1R32D61U)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize7mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-306-202 in 1 CARTON03/20/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/20/2022
Labeler - Genomma Lab USA (832323534)

Revised: 3/2022
Document Id: dbef3e9b-9f04-488b-943a-0e759b38781d
Set id: dfd40661-0d10-44e0-9059-03364475a7f5
Version: 2
Effective Time: 20220323
 
Genomma Lab USA