Children's Tukol Multi-symptom Cold & Flu   519

Children's Tukol Multi-symptom Cold & Flu   519
SPL v6
SPL
SPL Set ID 85fe6f0f-41c8-44d3-a34a-355938da5f72
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-04

Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

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

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.

Directions
  • this product does not contain directions or complete warning for adult use
  • do not give more than directed

    (see Overdose warning)
  • 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 = teaspoon
  • dose as follows
 age dose 
 children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours 
 children under 6 years of age do not use 

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.
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCL 5 mg

Questions?

Call 1-877-994-3666

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.

Other Information
  • each teaspoon 10 mL contains: sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • 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

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 occur
  • 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.

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.

Children's Tukol Multi Symptom Cold & Flu Product Label

KEEP CARTON FOR COMPLETE DRUG FACTS

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

Tukol®

Childrens

COLD & FLU

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

Ages 6-11

Relieves

Minor Aches & Pain

Fever

Nasal & Chest Congestion

4 FL OZ  (118 mL)

Distributed By

Genomma Lab USA Inc. Houston, TX 77098


Structured Label Content

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
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.

Directions
  • this product does not contain directions or complete warning for adult use
  • do not give more than directed

    (see Overdose warning)
  • 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 = teaspoon
  • dose as follows
 age dose 
 children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours 
 children under 6 years of age do not use 

Do Not Use (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.
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCL 5 mg

Questions?

Call 1-877-994-3666

Overdose Warning (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.

Other Information (Other information)
  • each teaspoon 10 mL contains: sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • keep carton for complete Drug facts
Inactive Ingredients (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

When Using This Product (When using this product)
  • do not exceed recommended dose ( see overdose section).
Stop Use and Ask A Doctor If (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 occur
  • 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.)

Keep out of reach of children.

Ask A Doctor Before Use If the Child Has (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 (Ask a doctor or pharmacist before use if the child is)

taking the blood thinning drug warfarin.

Children's Tukol Multi Symptom Cold & Flu Product Label (Children's Tukol Multi-Symptom Cold & Flu product label)

KEEP CARTON FOR COMPLETE DRUG FACTS

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

Tukol®

Childrens

COLD & FLU

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

Ages 6-11

Relieves

Minor Aches & Pain

Fever

Nasal & Chest Congestion

4 FL OZ  (118 mL)

Distributed By

Genomma Lab USA Inc. Houston, TX 77098


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)