TYLENOL COLD MULTI-SYMPTOM
Dosage form: solution
Ingredients: Acetaminophen 325mg in 15mL, Dextromethorphan Hydrobromide 10mg in 15mL, Doxylamine Succinate 6.25mg in 15mL, Phenylephrine Hydrochloride 5mg in 15mL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-269
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.
|Active ingredients (in each 15 mL = 1 tablespoon)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Dextromethorphan HBr 10 mg||Cough suppressant|
|Doxylamine succinate 6.25 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal decongestant|
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- runny nose and sneezing
- sinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you sleep
- temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dose
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 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.
If pregnant or breast-feeding, ask a health professional before use.
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.
- do not take more than directed (see overdose warning)
- mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
|adults and children 12 years and over||
|children under 12 years||ask a doctor|
- each 15 mL (1 TBSP) (½ FL OZ) contains: sodium 5 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- do not use if plastic neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
alcohol, anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
See New Warnings Information
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever/Fever Reducer, Nasal Decongestant, Antitussive, Antihistamine
Headache, Fever, Sore Throat
8 fl oz
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
|Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.