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  5. Label Information: Tukol Max Action Cold, Flu And Sore Throat

FDA Label for Tukol Max Action Cold, Flu And Sore Throat

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. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE CARTON

Tukol Max Action Cold, Flu And Sore Throat 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

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 even if you do not notice any signs or symptoms.

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


Otc - Purpose



Active ingredients (in each 20 mL)Purposes
Acetaminophen 650mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

Uses



  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • 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 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product.

Allergy Alert



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

If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vominting, consult a doctor promptly.


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 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.

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to enlarged prostate gland

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



  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • cough comes back or occuurs with fever, rash, or headache that lasts
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.

    • 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.


Directions



  • do not take more than directed
  • Do not take more than 4 doses in 24 hours.
  • This adult strength product is not intended for use in children under 12 years of age
  • Dose as follows or as directed by a doctor
  • Use dose cup provided
    • 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
  • store between 15-30°C (59-86°F), do not refrigerate

Inactive Ingredients



Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Questions Or Comments?



1-877-994-3666

Monday to Friday from 8 AM to 6 PM, Central time.


Principal Display Panel - 177 Ml Bottle Carton



NEW LOOK

Tukol®

MAX ACTION

COLD, FLU AND SORE THROAT

Acetaminophen/Dextromethorphan HBr/
Guaifenesin/Phenylephrine HCl

Ages
12+

MAX
STRENGTH

Relieves:

* Please review the disclaimer below.