Other
Drug Facts
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Tukol Max Action Cold And Flu Nighttime Relief (NDC 50066-520). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
| Active ingredients (in each 30 mL) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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:
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
| age | dose |
|---|---|
| adults & children 12 yrs & over | 30 mL every 6 hrs |
| children under 12 years of age | do not use |
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
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