Tukol® Children's Cold & Flu
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum 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
- 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 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 the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
When using this product
- do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
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.
Directions
| 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 |
- do not give more than directed (see Overdose warning)
- product not labeled with directions or warnings for adult use
- do not give more than 5 doses in any 24-hour period
- do not give 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=teaspoonful as bulleted statement.
Other information
- each 10 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F), do not refrigerate
- keep carton for complete Drug facts
Inactive ingredients
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
Questions?
Call 1-877-994-3666
SPL UNCLASSIFIED SECTION
Distributed by:Genomma Lab USA Inc.,Houston, TX 77027