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Name:Brotapp Pe-dm Cough And Cold Liquid
Manufacturer:Silarx Pharmaceutical, Inc
Category:Over-the-counter (OTC) Marketed Drugs

Brotapp PE-DM Cough & Cold

BROTAPP PE-DM COUGH AND COLD LIQUID  - brompheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid 
Silarx Pharmaceutical, Inc

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.


Brotapp PE-DM Cough & Cold

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


  •  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


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.


  • 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

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.



Manufactured by

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

Container Label 118mL

ontainer Label 237mL

brotapp pe-dm cough and cold liquid liquid
Product Information
Product Type HUMAN OTC DRUG 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) Brompheniramine maleate 1 mg  in 5 mL
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 2.5 mg  in 5 mL
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
citric acid  
FD&C blue no. 1  
FD&C red no. 40  
propylene glycol  
saccharin sodium  
sodium benzoate  
sodium citrate  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (Grape Flavor) Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:54838-147-40 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:54838-147-70 237 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/02/2001

Labeler - Silarx Pharmaceutical, Inc (161630033)

Revised: 06/2009 Silarx Pharmaceutical, Inc

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2020 by Dionisios Fentas || Terms of Use


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