Tukol Max Action Cold And Flu Nighttime Relief Syrup
FDA Label NDC 50066-520

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 Cold And Flu Nighttime Relief (NDC 50066-520). 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, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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 77098

Otc - Purpose

Active ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine

Uses

  • temporarily relieves these common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pain
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
    • relieves cough to help you sleep

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses (30 mL each) 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.

Otc - Do Not Use

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
  • 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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland
  • a sodium restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
  • taking any other pain reliever or fever reducer.

Otc - When Using

When using this product

  • 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
  • do not use more than directed.

Otc - Stop Use

Stop use and ask a doctor if

  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause severe liver damage and other serious health problems.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if there are no symptoms.

Directions

  • do not exceed 4 doses per 24 hours (see Overdose warning).
  • use the dosing cup provided and keep cup with product.
  • mL = milliliter
  • agedose
    adults & children 12 yrs & over30 mL every 6 hrs
    children under 12 years of agedo not use
    • when using day time and night time products, carefully read each label to ensure correct dosing.

Other Information

  • each (30 mL) contains: sodium: 45 mg
  • store at room temperature. Do not refrigerate.

Inactive Ingredients

Citric acid, FD&C Blue # 1, FD&C red# 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, Sodium benzoate, sodium chloride, sorbitol, 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

Acetaminophen / Dextromethorphan HBr / Doxylamine succinate

Tukol®
MAX ACTION NIGHT

SEVERE COLD & FLU

Ages
12+

NIGHTTIME RELIEF

RELIEVES
COUGH
FOR SLEEP

Relieves:
COUGH
HEADACHE, SORE THROAT, FEVER

MINOR ACHES AND PAINS

SNEEZING & RUNNY NOSE

6 FL OZ (177 mL)

Principal Display Panel (177 mL Bottle Carton)

Principal Display Panel (177 mL Bottle Carton)

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