Brotapp DM Cold and Cough
Dosage form: liquid
Ingredients: Brompheniramine maleate 1mg in 5mL, Pseudoephedrine hydrochloride 15mg in 5mL, Dextromethorphan hydrobromide 5mg in 5mL
Labeler: Silarx Pharmaceuticals, Inc
NDC Code: 54838-136
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.
Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL (teaspoon)(TSP))
Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL (teaspoon)(TSP))
Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL (teaspoon)(TSP))
Purpose of Brompheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Dextromethorphan hydrobromide: Cough Suppressant
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, or associated with sinusitis
- temporarily relieves 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
- runny nose
Do not use in children under 6 years of age
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.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
-
do not use more than directed
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsines
- 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 improve within 7 days or are accompanied by fever
- cough lasts morethan 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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.
- do not take more than 4 doses in any 24-hour period
| Adults and children 12 years and over | 4 teaspoons (TSP) every 6 hours |
| Children 6 to under 12 years | 2 teaspoons (TSP) every 6 hours |
| Children under 6 years | DO NOT USE |
Store at room temperature 20°-25°C (68°-77°F).
citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.
| BROTAPP DM COLD AND COUGH
brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid |
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| Labeler - Silarx Pharmaceuticals, Inc (161630033) |
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.
