Brotapp DM Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Brotapp DM Cold and Cough

Silarx Pharmaceuticals, Inc

Brotapp DM Cold & Cough Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

Uses

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

Warnings

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.

Directions

  • 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

Other information
Store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

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.

Questions

888-974-5279


Brotapp DM Cold and Cough

Brotapp DM Cold and Cough

Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-136
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
propylene glycol
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-136-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-136-70 237 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2001-04-05


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Be sure to consult your doctor before taking any medication!
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