DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG- dexbrompheniramine maleate and pseudoephedrine sulfate tablet, extended release 
KVK-TECH, INC.

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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 nose
    • sneezing
    • itching of the nose or throat
    • itchy 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

  • 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

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87f61316-figure-01

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

87f61316-figure-02
DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE  6MG/120MG
dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10702-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE6 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE 
CARNAUBA WAX 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POVIDONE 
STARCH, CORN 
PROPYLPARABEN 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize12mm
FlavorImprint Code K;5
Contains    
Packaging
#Item CodePackage Description
1NDC:10702-005-212 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:10702-005-0330 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07864802/27/2013
Labeler - KVK-TECH, INC. (173360061)
Registrant - AVANTHI (832316694)
Establishment
NameAddressID/FEIBusiness Operations
KVK-TECH, INC173360061MANUFACTURE(10702-005)

Revised: 02/2013
Document Id: 87f61316-7a82-4a7d-a23e-8285edc860d1
Set id: cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4
Version: 1
Effective Time: 20130227
 
KVK-TECH, INC.