Childrens SUDAFED PE Cold plus Cough
Dosage form: solution
Ingredients: Dextromethorphan hydrobromide 5mg in 5mL, Phenylephrine hydrochloride 2.5mg in 5mL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-785
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 5 mL)||Purposes|
|Dextromethorphan HBr 5 mg||Cough suppressant|
|Phenylephrine HCl 2.5 mg||Nasal decongestant|
- temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
- nasal congestion
Do not use 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.
- 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 sodium-restricted diet
When using this product do not exceed recommended dose
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough gets worse or lasts for more than 7 days
- cough tends to come back or occurs with fever, 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)
- find right dose on chart below
- mL = milliliters
- repeat dose every 4 hours
- do not give more than 6 times in 24 hours
|Age (yr)||Dose (mL)|
|under 4 years||do not use|
|4 to 5 years||5 mL|
|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.
- each 5 mL contains: sodium 14 mg
- store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
- do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
|CHILDRENS SUDAFED PE COLD PLUS COUGH
dextromethorphan hydrobromide 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.