Childrens TYLENOL COLD Plus FLU
Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL, Chlorpheniramine Maleate 1mg in 5mL, Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-456
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
COLD + FLU
|Active ingredients (in each 5 mL)||Purpose|
|Acetaminophen 160 mg||Pain reliever/fever reducer|
|Chlorpheniramine maleate 1 mg||Antihistamine|
|Dextromethorphan HBr 5 mg||Cough suppressant|
|Phenylephrine HCl 2.5 mg||Nasal decongestant|
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- stuffy nose
- sneezing and runny nose
- temporarily reduces fever
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
If a skin reaction occurs, stop use and seek medical help right away.
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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- to make a child sleepy
- in 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.
- if your child is allergic to any of the ingredients in this product
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- do not exceed recommended dose (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child's dose into the dosing cup
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
|Weight (lb)||Age (yr)||Dose (mL)|
|under 36||under 4 years||do not use|
|36-47||4 to 5 years||do not use unless directed by a doctor|
|48-95||6 to 11 years||10 mL|
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if carton tape or bottle wrap imprinted "TYLENOL" is broken or missing
anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
Acetaminophen, Pain Reliever-Fever Reducer
Chlorpheniramine Maleate, Antihistamine
Dextromethorphan HBr, Cough Suppressant
Phenylephrine HCl, Nasal Decongestant
Ages 6-11 Years
- SORE THROAT
- RUNNY NOSE
- STUFFY NOSE
4 fl oz (120 mL)
COLD PLUS FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension
|Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)|