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Brotapp

Silarx Pharmaceuticals, Inc

Brotapp Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL(TSP))

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL(TSP))

Purpose

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Uses

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
  • temporarily relieves these 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
  • breathing problem such as 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
  • drowsiness may occur
  • avoid alcoholic drinks
  • 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

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 teaspoonfuls (TSP) every 6 hours
Children 6 to under 12 years
2 teaspoonfuls (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, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.

Questions

888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512 USA


Brotapp


Brotapp

Brompheniramine maleate and Pseudoephedrine hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-125
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

Inactive Ingredients

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-125-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-125-70 237 in 1 BOTTLE, PLASTIC
3 NDC:54838-125-80 473 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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