![Q-TAPP (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [PREFERRED PHARMACEUTICALS, INC]](https://medic.hrt.org//dailymed/images/12789360-0d40-4cf3-99a3-271920752a55/container.jpg)
| NDC | 68788-9184-1 |
| Set ID | 12789360-0d40-4cf3-99a3-271920752a55 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Preferred Pharmaceuticals, Inc |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- ACTIVE INGREDIENT
Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL = 1 tsp)
Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL = 1 tsp)
Close - PURPOSE
Purpose of Brompheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Close - INDICATIONS & USAGE
Uses
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- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
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temporarily restores freer breathing through the nose
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temporarily relieves these symptoms due to hay fever (allergic rhinitis):
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runny nose
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sneezing
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itchy, watery eyes
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itching of the nose or throat
- Warnings
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Do not use in a child under 6 years of age
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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
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heart disease
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high blood pressure
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thyroid disease
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diabetes
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glaucoma
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trouble urinating due to an enlarged prostate gland
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- breathing problem such as emphysema or chronic bronchitis
When using this product
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do not use more than directed
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drowsiness may occur
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avoid alcoholic beverages
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alcohol, sedatives, and tranquilizers may increase drowsiness
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be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Stop use and ask a doctor if
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you get nervous, dizzy, or sleepless
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- symptoms do not get better within 7 days or are accompanied by fever
CloseKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
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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
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each tsp contains: sodium 2 mg
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- 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.
Close - Questions
Made in the USA
for Qualitest Pharmaceuticals
130 Vintage Drive
Huntsville, AL 35811Relabeled By:
Close
Preferred Pharmaceuticals, Inc
Anaheim, CA 92807 - INGREDIENTS AND APPEARANCE
Q-TAPP
brompheniramine maleate and pseudoephedrine hydrochloride elixirProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/05/2001 Labeler - Preferred Pharmaceuticals, Inc (791119022) Registrant - Preferred Pharmaceuticals, Inc (791119022) CloseEstablishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc 791119022 RELABEL(68788-9184)