- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Brompheniramine Maleate, USP 4 mg
Dextromethorphan HBr, USP 15 mg
Phenylephrine HCl, USP 7.5 mg
|Dextromethorphan HBr||Cough Suppressant|
|Phenylephrine HCl||Nasal Decongestant|
temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:
- runny nose
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
- relieves cough associated with the common cold
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, 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.
- heart disease
- high blood pressure
- thyroid disease
- a breathing problem, or persistent or chronic cough such as occurs with smoking, asthma, emphysema or chronic bronchitis
- cough accompanied by excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland.
taking sedatives or tranquilizers.
- Do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages.
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- do not exceed 6 doses in a 24 hour period
|adults and children 12 years of age and over||1 teaspoonful (5 mL) every 4 to 6 hours|
|children 6 years to under 12 years of age||1/2 teaspoonful (2.5 mL) every 4 to 6 hours|
|children under 6 years of age||ask a doctor|
- do not use if tamper evident seal under cap is broken or missing
- store between 20° - 25° C (68° - 77° F).
citric acid, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, strawberry flavor.
Ballay Pharmaceuticals, Inc.
Wimberley, Texas 78676
Each teaspoonful (5 mL) for oral
Maleate .............................. 4 mg
Hydrobromide .................... 15 mg
Hydrochloride ................... 7.5 mg
For Professional Use Only
Sugar Free/Alcohol Free/
BALLAY 16 fl oz. (473 mL)
Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID