Childrens SUDAFED PE Cold and Cough
Dosage form: solution
Ingredients: Dextromethorphan hydrobromide 5mg in 5mL, Phenylephrine hydrochloride 2.5mg in 5mL
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
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.
Drug Facts
| Active ingredients (in each 5 mL) | Purpose |
|---|---|
|
|
| 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:
- cough
- nasal congestion
- 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
- 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
- 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
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours
- do not give more than 6 times in 24 hours.
| Age (yr) | Dose (tsp) |
|---|---|
| under 4 years | do not use |
| 4 to 5 years | 1 teaspoonful (5 mL) |
| 6 to 11 years | 2 teaspoonfuls (10 mL) |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- each teaspoon contains: sodium 15 mg
- store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
- do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
- see bottom panel for lot number and expiration date
anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
call 1-888-217-2117
NDC 50580-785-04
NON-DROWSY
children's
SUDAFED PE®
COLD &
COUGH
- ✔
-
Sinus Pressure
& Stuffy Nose
Phenylephrine HCl - ✔
-
Cough
Dextromethorphan
HBr
Grape
Flavor Liquid
Alcohol & Sugar Free
4 fl oz (118 mL)
| CHILDRENS SUDAFED PE COLD AND COUGH
dextromethorphan hydrobromide and phenylephrine hydrochloride solution |
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| Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
