Childrens Tukol Multi-symptom Cold And Flu Liquid
FDA Label NDC 50066-519

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, Inc. for the product Childrens Tukol Multi-symptom Cold And Flu (NDC 50066-519). 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 drug factsactive ingredients(in each 10 ml = 2 teaspoonful), purpose, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients(In Each 10 Ml = 2 Teaspoonful)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal 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

Warnings

Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes

  • more tha 5 doses in 24 hours which is the maxium daily amount
  • with other drugs containing acetaminophen

    • 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 more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug containd acetaminophen, ask a doctor or pharmacist
  • for a child who is 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 an MAOI drug. If you do not know if ask a doctor or pharmacist beforre giving this product.

Ask A Doctor Before Use If The Child Has

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistant or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (musus)

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking the blood thinning drug warfarin.

When Using This Product

  • do not exceed recommended dose ( see overdose section).

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • new symptoms
  • fever gets worse or lasts more than 3 days
  • cough comes back, or occurs with rash or headache that lasts

    • These could be signs of a serious condition.

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attentioni is critical even if you do not notice any signs or symptoms.

Directions

  • do not give more than directed
    (see Overdose warning)
  • product not labeled with directions for adult use
  • do not give more than 5 doses in any 24-hour period
  • do not give for more than 5 days unless directed by a doctor
  • measure only with dosing cup provided
  • dose as follows or as directed by a doctor
  • mL = milliliter; tsp - teaspoonful

    • Age                                                                    dose

    Children 6 to under 12 years of age                     10 mL or 2 tsp every 4 hours

    Children under 6 years of age                               do not use

Other Information

  • each 10 mL contains: sodium 6 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
  • keep carton for complete Drug facts

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, orbitol, sucralsoe, xanthan gum

Questions?

Call 1-877-99-GENOMA (43666)

Children's Tukol Multi-Symptom Cold & Flu Product Label

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Children's Tukol®

Acetaminophen/Guaifenesin/Dextromethorphan HBr/Phenylephrine HCL
Pain Reliever/Fever Reducer/Expectorant/Cough Suppressant/Nasal Congestion

NEW!

Multi-Symptom Cold & Flu

Ages 6-11

Fever•Sore Throat•
Stuffy Nose
Cough•Phlegm

BERRY flavor

4 FL OZ  (118 mL)

Distributed By
Genomma Lab USA Inc. Houston, TX 77027

BX-057

Lot:

Exp:

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