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  5. Label Information: Tukol Max Action Sinus Caplets

FDA Label for Tukol Max Action Sinus Caplets

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. ALLERGY ALERT
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 20 CAPLET BLISTER PACK CARTON

Tukol Max Action Sinus Caplets Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


Otc - Purpose



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

Uses



  • temporarily relieves:
    • nasal congestion
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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)

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 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.

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



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



  • do not take more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use

Other Information



  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

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


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

* Please review the disclaimer below.