Childrens Tukol Multi-Symptom Cold and Flu

Manufacturer
Genomma Lab USA, Inc. | AptaPharma Inc. | Rnv LLC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:02

Label at a glance#

ProductChildrens Tukol Multi-Symptom Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and 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

Dosage and administration

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 ag...

Label contents#

Full prescribing information#

Drug FactsActive ingredients(in each 10 mL = 2 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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
 agedose 
 children 6 to under 12 years of age2 teaspoons (10 mL) every 4 hours 
 children under 6 years of agedo not use 

Other information

OTHER SAFETY 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-877-994-3666

Children's Tukol Multi-Symptom Cold & Flu product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLE Berry KidsPLE Berry Kids

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN6
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY6
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY6
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-519-242024-01-11C16284748780-10191ceaa-6e4a-198a-e063-dbdaa90aec3eChildren's Tukol Multi-Symptom Cold & Flu 519
50066-519-242023-07-28C16284748780-10191ceaa-6e4a-198a-e063-dbdaa90aec3eChildren's Tukol Multi-Symptom Cold & Flu 519

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-519-24Childrens Tukol Multi-Symptom Cold and Flu118 mL in 1 BOTTLELIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-519CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]6Current NDC, Legacy NDC, 1 package rows20240112_85fe6f0f-41c8-44d3-a34a-355938da5f72.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-51950066-519-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
ndc (package): 50066-519-24
ndc (product): 50066-519
ndc11 (package): 50066051924
spl id: 4aa9c4b3-12e4-4e80-9765-be13234ba585
spl set id: 85fe6f0f-41c8-44d3-a34a-355938da5f72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.