Tukol Day Time Cold And Flu Relief Softgels
FDA Label NDC 50066-312

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 Day Time Cold And Flu Relief Softgels (NDC 50066-312). 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.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77098

Otc - Purpose

Active ingredients
(in each softgel) 		Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

temporarily relieves common cold and flu symptoms:

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • 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

  • with any other products 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 drugs. 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin

When Using This Product

  • do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.
  • a skin reaction occurs. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Directions

  • take only as directed (see Warnings)
  • do not exceed 4 doses per 24 hours
    Adults and children 12 years and over: take 2 softgels with water every 4 hours
    Children 4 to under 12 years: Ask a doctor
    Children under 4 years: Do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing

Other Information

  • store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified Water, Sorbitol sorbitan solution, Titanium dioxide.

Questions Or Comments?

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Principal Display Panel - 24 Softgel Blister Pack Carton

NEW
Non Drowsy

Tukol®

DAY TIME
COLD AND FLU RELIEF

Acetaminophen / Dextromethorphan HBr /
Phenylephrine HCl

  • COUGH
  • FEVER
  • SORE THROAT
  • ACHES
  • NASAL CONGESTION

    • 24 Softgels

    Principal Display Panel (24 Softgel Blister Pack Carton)

    Principal Display Panel (24 Softgel Blister Pack Carton)

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