FDA Label for Q-tapp Dm Elixir
View Indications, Usage & Precautions
Q-tapp Dm Elixir Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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)
Otc - Purpose
Purpose of Brompheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Dextromethorphan hydrobromide: Cough Suppressant
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
Warnings
Do not use in children under 6 years of age
Otc - Do Not Use
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.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
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
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- each tsp contains: sodium 2 mg
- Store at room temperature 20°-25°C (68°-77°F).
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 |
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.
Questions
Made in USAfor Qualitest Pharmaceuticals130 Vintage DriveHuntsville, AL 35811
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