Q TAPP COLD AND ALLERGY- brompheniramine maleate and pseudoephedrine hcl liquid 
Qualitest Pharmaceuticals

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.

----------

Q-Tapp Cold and Allergy Grape Flavor

Active ingredients (in each 5 mL = 1 tsp)

Brompheniramine maleate, USP 1 mg

Pseudoephedrine HCI, USP 15 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

  • to sedate a child or to make a child sleepy
  • 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
  • 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 any other oral nasal decongestant or stimulant
  • 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

  • use an accurate measuring device to administer this medication 
  • do not take more than 4 doses in any 24-hour period

 adults and children
 12 years and over

 4 tsp every
 4 hours 

 children 6 years to
 under 12 years

 2 tsp every
 4 hours

 children under 6 years

 do not use

Other information

  • each tsp contains: sodium 2 mg
  • store at 15°- 30°C (59°- 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/15 R4
8073560  0851

PRINCIPAL DISPLAY PANEL

Label of Q-Tapp Cold & Allergy Grape flavor
Q TAPP COLD AND ALLERGY 
brompheniramine maleate and pseudoephedrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0851
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLE (clear) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0851-561 in 1 CARTON04/03/200209/30/2017
1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0603-0851-541 in 1 CARTON04/03/200209/30/2017
2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0603-0851-81237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/200209/30/2017
4NDC:0603-0851-94118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/200209/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/03/200209/30/2017
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0851)

Revised: 10/2016
 
Qualitest Pharmaceuticals