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

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Brotapp PE-DM Cough and Cold Liquid

Silarx Pharmaceutical, Inc

Brotapp PE-DM Cough & Cold


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts                                                      Purpose

Active ingredients ( in each 5 mL)                                                            

  • Brompheniramine maleate 1 mg                         Antihistamine
  • Phenylephrine hydrochloride 2.5 mg                   Nasal Decongestant
  • Dextromethorphan hydrobromide 5 mg               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 a child 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 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 improve within 7 days or are accompanied by fever
  • cough lasts more than 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 6 doses in any 24-hour period

Adults and children 12 years and over
4 teaspoonfuls every 4 hours
Children 6 to under 12 years
2 teaspoonfuls every 4 hours
Children under 6 years
DO NOT USE

Other information

  • Store at 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

Manufactured by

Silarx Pharamceuticals. Inc
19 West Steet
Spring Vally, NY-10977, USA.


Brotapp PE-DM Cough and Cold Liquid


Brotapp PE-DM Cough and Cold Liquid


Brotapp PE-DM Cough and Cold Liquid

Brotapp PE-DM Cough and Cold Liquid LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-147
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
propylene glycol
saccharin sodium
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-147-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-147-70 237 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2001-04-02


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Be sure to consult your doctor before taking any medication!
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