CHILDRENS SUDAFED PE COLD PLUS COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride solution
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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.
----------
Children's SUDAFED PE Cold plus Cough
Uses
- temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
- cough
- nasal congestion
- sinus congestion and pressure
Warnings
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.
Ask a doctor before use if the child has
- 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)
- a sodium-restricted diet
Stop use and ask a doctor if
- 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.
Directions
- 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.
Other information
- 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 tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
| CHILDRENS SUDAFED PE COLD PLUS COUGH
dextromethorphan hydrobromide and phenylephrine hydrochloride solution |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
| Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358) |