Tukol Max Action Cold and Flu Nighttime Relief

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Tukol Max Action Cold and Flu Nighttime Relief
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE
Manufacturer
Genomma Lab USA
Product type
HUMAN OTC DRUG
SPL set ID
cf0987a3-2c1d-4f40-8551-df9a8e08cd3d
SPL ID
d0742123-2ccf-4a19-901c-20b17db981f2
Version
1
Effective date
2026-08-03
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:37:32
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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. 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. 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 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. 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. 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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.

Reported adverse events (FAERS/openFDA)#

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