FDA Label for Tukol Honey Daytime Cold And Flu

View Indications, Usage & Precautions

Tukol Honey Daytime Cold And Flu 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 15 mL)Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal Decongestant

Uses



Temporarily relieves cold/flu symptoms:

  • minor aches and pain
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Liver Warning



The product contains Acetaminophen. Severe liver damage may occur if you take

  • more than 4 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 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 vomiting, consult a doctor promptly.


Do Not Use



  • 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 two 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use



  • if you are taking the blood thinning drug warfarin

When Using This Product



Stop Use And Ask A Doctor If



  • you get nervous, dizzy or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • 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



Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.


Directions



  • take only as recommended (see Overdose warning)
  • use dosage cup
  • do not exceed 4 doses per 24 hours
  • agedose
    adults and children 12 years and over30 mL every 4 hours
    Children under 12 yearsDo not use
    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other Information



  • each 15 mL contains sodium: 5 mg
  • store at room temperature

Inactive Ingredients



Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose


Questions?



1-877-994-3666


Principal Display Panel - 118 Ml Bottle Carton



NEW

Day Time

Tukol®

HONEY MULTI SYMPTOM

COLD & FLU

Acetaminophen / Dextromethorphan HBr
/ Phenylephrine HCl

Ages
12+

NATURAL
HONEY
FLAVOR

Relieves:

* Please review the disclaimer below.