Dexbrompheniramine maleate 6 mg Pseudoephedrine Sulfate 120 mg
SPL UNCLASSIFIED SECTION
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Dexbrompheniramine maleate 6 mg
Pseudoephedrine Sulfate 120 mg
PURPOSE
Antihistamine
Nasal decongestant
USES
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitis
- helps decongest sinus openings and sinus passages
- reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
- temporarily alleviates the following symptoms due to hay fever (allergic rhinitis):runny nosesneezingitching of the nose or throatitchy and watery eyes
WARNINGS
Do not use If you are now taking a prescription monoamineoxidase 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE
- taking sedative or tranquilizers
WHEN USING THIS PRODUCT
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
You may report side effects to FDA at 1-800-FDA 1088
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a 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
- adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
- children under 12 years of age: ask a doctor
OTHER INFORMATION
- each tablet contains: calcium 69 mg and sodium 0 mg
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
INACTIVE INGREDIENTS
calcium sulfate, carnauba wax, colloidal silicon dioxide, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6 aluminum lake, gelatin, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, pregelatinized maize starch, propyl parahydroxy benzoate, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate
QUESTIONS
call 1-215-579-1842
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Dexbrompheniramine Maleate 6 mg
and Pseudoephedrine Sulfate 120 mg
Extended-release Tablets
Antihistamine/Nasal Decongestant
COLD & ALLERGY
Maximum Strength
- Nasal & Sinus Congestion
- Runny Nose, Sneezing
- Itchy, Watery Eyes12 Hour Sustained Relief20 EXTENDED-RELEASE TABLETSSAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE 6 mg AND PSEUDOEPHEDRINE SULFATE 120 mg IS TORN OR MISSING.Manufactured by KVK-TECH, INC.Newtown, PA18940 MADE IN USA