Children's SUDAFED PE Cold plus Cough
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: coughnasal congestionsinus congestion and pressure
Warnings
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
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
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
Directions
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| under 4 years | do not use |
| 4 to 5 years | 5 mL |
| 6 to 11 years | 10 mL |
- find right dose on chart below
- mL = milliliters
- repeat dose every 4 hours
- do not give more than 6 times in 24 hours
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
Inactive ingredients
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