Q-Tapp by Preferred Pharmaceuticals, Inc Q-Tapp Elixir

Q-Tapp by

Drug Labeling and Warnings

Q-Tapp by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Q-TAPP- brompheniramine maleate and pseudoephedrine hydrochloride elixir 
Preferred Pharmaceuticals, 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.

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Q-Tapp Elixir

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

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL = 1 tsp)

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
• temporarily restores freer breathing through the nose
  
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  
  • runny nose
    
  • sneezing
    
  • itchy, watery eyes
    
  • itching of the nose or throat
    

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 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 4 doses in any 24-hour
  

• Adults and children 12 years and over:

  20 mL (4 tsp) every 4 to 6 hours;

• Children 6 years to under 12 years:

  10 mL (2 tsp) every 4 to 6 hours;

• Children under 6 years:

  DO NOT USE

Other information

• each tsp contains: sodium 2 mg
  
• 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

Made in the USA
for Qualitest Pharmaceuticals
130 Vintage Drive
Huntsville, AL 35811

Relabeled By:
Preferred Pharmaceuticals, Inc
Anaheim, CA 92807

Q-TAPP 
brompheniramine maleate and pseudoephedrine hydrochloride elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9184(NDC: 0603-0863)
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
Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine hydrochloride	15 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)
propylene glycol (UNII: 6DC9Q167V3)
saccharin sodium (UNII: SB8ZUX40TY)
sodium benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
sorbitol (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9184-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2001	12/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/05/2001	12/06/2019

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Registrant - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc		791119022	RELABEL(68788-9184)

Revised: 12/2019

Document Id: e78eeaca-3b01-4dd6-8929-c7a263a5e265

34390-5

Set id: 12789360-0d40-4cf3-99a3-271920752a55

Version: 3

Effective Time: 20191206

 

Preferred Pharmaceuticals, Inc