![Q TAPP COLD AND COUGH (BROMPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR AND PSEUDOEPHEDRINE HCL) LIQUID [PREFERRED PHARMACEUTICALS INC.]](https://medic.hrt.org//dailymed/images/6a09c18d-1ba3-4ba5-a6b1-124412870445/q-tappcoldcough-1.jpg)
| NDC | 68788-6918-1 |
| Set ID | 6a09c18d-1ba3-4ba5-a6b1-124412870445 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Preferred Pharmaceuticals Inc. |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 5 mL = 1 tsp)
Brompheniramine maleate, USP 1 mg
Dextromethorphan HBr, USP 5 mg
Pseudoephedrine HCI, USP 15 mg
Close - Purpose
- Uses
- •
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and 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
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Ask a doctor or pharmacist before use if you are
- When using this product
- •
- do not use more than directed
- •
- marked 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
- •
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
Close - PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- •
- use an accurate measuring device to administer this medication
- •
- do not take more than 4 doses in any 24-hour period
Closeadults and children
12 years and over4 tsp every
4 hourschildren 6 years to
under 12 years2 tsp every
4 hourschildren 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.
Close - Inactive ingredients
citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Close - SPL UNCLASSIFIED SECTION
Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811Rev. 1/15 R4
8073581 0852Relabeled By: Preferred Pharmaceuticals Inc.
Close - PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Q TAPP COLD AND COUGH
brompheniramine maleate and dextromethorphan hbr and pseudoephedrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6918(NDC:0603-0852) 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 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) 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 Color RED (clear and dark red) Score Shape Size Flavor GRAPE (red grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-6918-1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/21/2017 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) CloseEstablishment Name Address ID/FEI Business Operations Preferred PharmaceuticalsInc. 791119022 RELABEL(68788-6918)
