Topco Associates LLC. Children’s Night Time Cold & Cough Drug Facts
Active ingredients (in each 5 mL)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Purposes
Antihistamine/cough suppressant
Nasal decongestant
Uses
- •temporarily relieves:
- •sneezing
- •itchy nose or throat
- •runny nose
- •itchy, watery eyes due to hay fever
- •nasal and sinus congestion
- •cough due to minor throat and bronchial irritation as may occur with a cold
Warnings
Do not use
- •in a child under 4 years of age
- •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.
- •with any other product containing diphenhydramine, even one used on skin
- •to make a child sleepy
Ask a doctor before use if the child has
- •heart disease
- •high blood pressure
- •thyroid disease
- •diabetes
- •glaucoma
- •cough that occurs with too much phlegm (mucus)
- •chronic cough that lasts or as occurs with asthma
- •a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if the child is
taking sedatives or tranquilizers
When using this product
- •do not exceed recommended dosage
- •may cause marked drowsiness
- •sedatives and tranquilizers may increase drowsiness
- •excitability may occur, especially in children
Stop use and ask a doctor if
- •nervousness, dizziness or sleeplessness occurs
- •symptoms do not get better within 7 days or occur with fever
- •cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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).
Directions
| Age | Dose |
| children under4 years of age | do not use |
| children 4 to under6 years of age | do not use unlessdirected by a doctor |
| children 6 to under12 years of age | 10 mL |
- •may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- •use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.
Other information
- •each 5 mL contains: sodium 3 mg
- •store at 20-25°C (68-77°F)
Inactive ingredients
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate