Other
Drug Facts
Distributed by:
Genomma Lab USA Inc.,Houston, TX 77027
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Tukol Childrens Cold And Flu (NDC 50066-315). 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, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if the child has, 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 77027
| Active ingredients (in each 10 mL or 2 teaspoonful) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Temporarily relieves these common cold and flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
These could be signs of a serious condition.
Keep out of reach of children.
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 attention is critical even if you do not notice any signs or symptoms.
| Age | Dose |
|---|---|
| Children 6 to under 12 years of age | 10 mL or 2 tsp every 4 hours |
| Children under 6 years of age | do not use |
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Call 1-877-994-3666
* Please review the disclaimer below.