The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each 5 mL)Diphenhydramine HCI, USP 6.25 mg Phenylephrine HCI, USP 2.5 mg
Otc - Purpose
PurposeDiphenhydramine HCI, USP Antihistamine/Cough suppressantPhenylephrine HCI, USP Nasal decongestant
Indications & Usage
Uses• temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold• temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: • sneezing • runny nose • itchy, watery eyes • itchy nose or throat
WarningsDo not use• with any other product containing diphenhydramine, even one used on the skin• to make a child sleepy• if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if the child has• heart disease • high blood pressure •thyroid disease• diabetes • glaucoma• abreathing problem such as chronic bronchitis• persistent or chronic cough such as occurs with asthma• cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is• taking sedatives or tranquilizers.
Otc - When Using
When using this product• do not use more than directed• excitability may occur, especially in children• marked drowsiness may occur• sedatives and tranquilizers may increase drowsiness
Otc - Stop Use
Stop use and ask a doctor if• nervousness, dizziness or sleeplessness occur• symptoms do not get better within 7 days or occur with fever• cough lasts more than 7 days, comes back, or occurswith fever, rash, or persistent headache.These could be signs of a serious condition.
Otc - 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.
Dosage & Administration
Directions do not use more than directed do not take more than 6 doses in any 24-hour period mL=milliliterAge Dose Children 6 to under 12 years of age 10 mL every 4 hours Children 4 to under 6 years of age Do not use unless directed by a doctor Children under 4 years of age Do not use
Other Safety Information
Other information• each 10 mL contains: sodium 3 mg• store between 20-25°C (68-77°F)• do not refrigerate• dosing cup provided
Inactive ingredientsanhydrous citric acid, flavor, purified water, sodium benzoate, sucrose
* Please review the disclaimer below.