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Brotapp PE-DM Cough and Cold Liquid

Dosage form: liquid
Ingredients: Brompheniramine maleate 1mg in 5mL, Phenylephrine hydrochloride 2.5mg in 5mL, Dextromethorphan hydrobromide 5mg in 5mL
Labeler: Silarx Pharmaceutical, Inc
NDC Code: 54838-147

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


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 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-147
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine maleate (Brompheniramine) Brompheniramine maleate1 mg  in 5 mL
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride2.5 mg  in 5 mL
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
propylene glycol 
saccharin sodium 
sodium benzoate 
sodium citrate 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54838-147-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-147-70237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/02/2001
Labeler - Silarx Pharmaceutical, Inc (161630033)

Revised: 06/2009
 
Silarx Pharmaceutical, Inc

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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