BROM TAPP- brompheniramine maleate, phenylephrine hcl liquid

Brom Tapp by

Drug Labeling and Warnings

Brom Tapp by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each 5mL tsp)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl , USP 2.5 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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

• 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 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
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a 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 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 get better 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 6 doses in any 24-hour period

age	dose
adults and children 12 years and over	4 tsp every 4 hours
children 6 to under 12 years	2 tsp every 4 hours
children under 6 years	ask a doctor

Other Information

• TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
• each teaspoon (5 ml) contains: sodium 5 mg
• store at room temperature 15º - 30ºC (59º - 86ºF)
• not a USP elixir

INACTIVE INGREDIENTS

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROM TAPP 
brompheniramine maleate, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-529
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-529-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-529-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
Rij Pharmaceutical Corporation		144679156	manufacture(53807-529)