FDA.reportPublic FDA data

Tukol

Manufacturer
Genomma Lab USA
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-07 01:01:06

Label at a glance#

ProductTukol Max Action Cold and Flu Nighttime Relief
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Label structure10 sections

Indications and 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

Dosage and administration

do not exceed 4 doses per 24 hours (see Overdose warning ). use the dosing cup provided and keep cup with product. mL = milliliter age dose adults & children 12 yrs & over 30 mL every 6 hrs children under 12 years of age do not use when using day time and night time products, carefully read each label to ensure correct dosing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-52050066-520-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Doxylamine SuccinateV9BI9B5YI2ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Sorbitol506T60A25RIACT
Sodium benzoateOJ245FE5EUIACT
Saccharin sodiumSB8ZUX40TYIACT

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
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
ndc (package): 50066-520-06
ndc (product): 50066-520
ndc11 (package): 50066052006
spl id: d0742123-2ccf-4a19-901c-20b17db981f2
spl set id: cf0987a3-2c1d-4f40-8551-df9a8e08cd3d

Reported adverse events (FAERS/openFDA)#

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