Topco Associates LLC. Children’s Cold and Cough Drug Facts
Active ingredients (in each 10 mL)
Brompheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 10 mg
Phenylephrine HCl, USP 5 mg
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- •temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- •temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- •runny nose
- •sneezing
- •itchy, watery eyes
- •itching of the nose or throat
- •temporarily restores freer breathing through the nose
Warnings
Do not use
- •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.
- •to make a child sleepy
Ask a doctor before use if you have
- •heart disease
- •high blood pressure
- •thyroid disease
- •diabetes
- •trouble urinating due to an enlarged prostate gland
- •glaucoma
- •cough that occurs with too much phlegm (mucus)
- •a breathing problem such as emphysema or chronic bronchitis
- •cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
- •do not use more than directed
- •may cause marked drowsiness
- •avoid alcoholic beverages
- •alcohol, sedatives, and tranquilizers may increase drowsiness
- •be careful when driving a motor vehicle or operating machinery
- •excitability may occur, especially in children
Stop use and ask a doctor if
- •you get nervous, dizzy, or sleepless
- •symptoms do not get better within 7 days or are accompanied by fever
- •cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
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 |
| adults and children 12 years and over | 20 mL every 4 hours |
| children 6 to under 12 years | 10 mL every 4 hours |
| children under 6 years | do not use |
- •do not take more than 6 doses in any 24-hour period
- •measure only with dosage cup provided
- •keep dosage cup with product
- •mL = milliliter
Other information
- •each 10 mL contains: sodium 4 mg
- •store at 20°-25°C (68°-77°F)
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution