Tukol Honey Daytime Cold And Flu Syrup
FDA Label NDC 50066-302

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 Honey Daytime Cold And Flu (NDC 50066-302). 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, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Cold & Flu Day Time Multi-Symptom Relief with Natural Honey

Drug Facts

Cold & Flu Night Time Multi-Symptom Relief with Natural Honey

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
Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine Succinate 12.5 mgAntihistamine

Uses

Temporarily relieves cold/flu symptoms:

  • minor aches and pain
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • Temporarily relieves cold/flu symptoms:

    • sore throat
    • headache
    • minor aches and pain
    • fever
    • runny nose and sneezing
    • 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.
  • 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.

    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.

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.
    • with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    • for more than 10 days for pain unless directed by a doctor.
    • for more than 3 days for fever unless directed by a doctor
    • 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.
    • to make a child sleepy

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)
    • liver disease
    • glaucoma;
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to an enlarged prostate gland.

Ask A Doctor Or Pharmacist Before Use

  • if you are taking the blood thinning drug warfarin
    • if you are taking sedatives or tranquillizers
    • if you are taking the blood thinning drug warfarin

When Using This Product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
    • do not use more than directed
    • avoid alcoholic drinks
    • excitability may occur, especially in children,
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

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.
    • 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 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.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause serious health problems. 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 noticve any signs or symptoms.

Taking more than the recommended dose may cause serious health problems. 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 noticve any signs or symptoms.

Directions

  • take only as recommended (see Overdose warning)
  • use dosage cup
  • do not exceed 4 doses per 24 hours
  • 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.
    • take only as recommended see Overdose warning
    • use dosage cup
    • do not exceed 4 doses per 24 hours
    • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
    • Adults and children 12 years and over30 mL every 6 hours
      Children 4 to under 12 yearsAsk a doctor
      Children under 4 yearsDo not use

Other Information

  • Each 15 mL contains sodium: 5 mg
  • store at room temperature
    • Each 30 mL contains sodium 10 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

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

Questions Or Comments?

1-877-994-3666

1-877-994-3666

Principal Display Panel - 118 Ml Kit Carton

NEW

Tukol®
HONEY

Day Time
Multi symptom

VALUE PACK
COLD & FLU

Acetaminophen/ Dextromethorphan HBr /
Phenylephrine HCl

Ages
12+

NATURAL

HONEY
FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • NASAL CONGESTION AND COUGH
  • 4 FL OZ (118 ml)

    Night Time
    Multi symptom

    Acetaminophen/ Dextromethorphan HBr /
    Doxylamine succinate

    Ages
    12+

    NATURAL

    HONEY
    FLAVOR

    Relieves:

    • HEADACHE, SORE THROAT, FEVER
    • MINOR ACHES AND PAINS
    • SNEEZING, RUNNY NOSE
    • COUGH
    • 4 FL OZ (118 ml)

      Principal Display Panel (118 ml Kit Carton)

      Principal Display Panel (118 ml Kit Carton)

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