Tukol Max Action Sinus Liquid
FDA Label NDC 50066-305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Tukol Max Action Sinus Liquid (NDC 50066-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

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

Otc - Purpose

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

Uses

temporarily relieves:

  • nasal congestion
  • headache
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily promotes nasal and sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

  • take only as recommended (see Overdose warning)
  • use dosage cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period
  • AgeDose
    Adults and children 12 years and older20 mL every 4 hours
    Children under 12 years of ageDo not use

Other Information

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30°C (59-86°F)
  • do not refrigerate

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

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)

    Principal Display Panel (177 ml Bottle Carton)

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