Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 50580-785-04 children's SUDAFED ® PE non-drowsy COLD + COUGH Phenylephrine HCl • Dextromethorphan HBr Nasal Decongestant • Cough Suppressant Oral Solution RELIEF OF Stuffy Nose Sinus Pressure Cough Grape FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL NDC 50580-785-04 children's SUDAFED ® PE non-drowsy COLD + COUGH Phenylephrine HCl • Dextromethorphan HBr Nasal Decongestant • Cough Suppressant Oral Solution RELIEF OF Stuffy Nose Sinus Pressure Cough Grape FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) PRINCIPAL DISPLAY PANEL
Overview
Uses temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion sinus congestion and pressure
Indications & Usage
Uses temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion sinus congestion and pressure
Dosage & Administration
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.
Warnings & Precautions
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 When using this product do not exceed recommended dose 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. 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)
Purpose
Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant
Do Not Use
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.
When Using
When using this product do not exceed recommended dose
Stop Use & Ask a Doctor
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.
Keep Out of Reach of Children
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)
Storage & Handling
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
Questions
Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
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