NDC | 68788-0852-0 |
Set ID | 0654b093-2067-492f-a0bc-647dac430bde |
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)
Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL = 1 tsp)
Close - PURPOSE
Purpose of Brompheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Dextromethorphan hydrobromide: Cough Suppressant
Close - INDICATIONS & USAGE
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, or associated with sinusitis
- temporarily relieves 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
- runny nose
- 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, or associated with sinusitis
- Warnings
Do not use in children 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
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis
When using this product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsines
- 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 improve 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- heart disease
- 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 - each tsp contains: sodium 2 mg
- Store at room temperature 20°-25°C (68°-77°F).
- do not take more than 4 doses in any 24-hour
- Inactive ingredients
citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.
Close - Questions
- INGREDIENTS AND APPEARANCE
Q-TAPP DM ELIXIR
brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide elixirProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0852(NDC:0603-0864) 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 Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide 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) saccharin sodium (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (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:68788-0852-0 118 mL in 1 BOTTLE, PLASTIC 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) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc 791119022 repack