Dexbrompherniramine Maleate and Pseudoephedrine Sulfate

KVK-TECH, INC.
AVANTHI

Dexbrompheniramine maleate 6 mg Pseudoephedrine Sulfate 120 mg

FULL PRESCRIBING INFORMATION

DRUG FACTS

Dexbrompheniramine maleate 6 mg

Pseudoephedrine Sulfate 120 mg

Antihistamine

Nasal decongestant

• 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 nose
  • sneezing
  • itching of the nose or throat
  • itchy and watery eyes

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.

• 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

• taking sedative or tranquilizers

• 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

• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

You may report side effects to FDA at 1-800-FDA 1088

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

• 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

• each tablet contains: calcium 69 mg and sodium 0 mg
• store between  20° to 25°C (68° to 77°F)
• protect from excessive moisture

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

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 Eyes

  12 Hour Sustained Relief

  20 EXTENDED-RELEASE TABLETS

  SAFETY 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

NDC-10702-005-03

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 Eyes

12 Hour Sustained Relief

30 EXTENDED-RELEASE TABLETS

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.

Manufactured by KVK-TECH, INC.

Newtown, PA18940 MADE IN USA