DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG- dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate by

Drug Labeling and Warnings

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate by is a Otc medication manufactured, distributed, or labeled by KVK-TECH, INC., AVANTHI, KVK-TECH, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

Principal Display Panel

Carton Label

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 Relief

20 EXTENDED-RELEASE TABLETS

Container Label

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 Congestionunny Nose, Sneezing
• Itchy, Watery Eyes12 Hour Sustained Relief

30 EXTENDED-RELEASE TABLETS

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

INGREDIENTS AND APPEARANCE

DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE  6MG/120MG
dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10702-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	6 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
METHYLPARABEN (UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	GREEN	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	K;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10702-005-21	2 in 1 CARTON	12/17/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 10702-005-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078648	12/17/2018

Labeler - KVK-TECH, INC. (173360061)

Registrant - AVANTHI (832316694)

Establishment
Name	Address	ID/FEI	Business Operations
KVK-TECH, INC		173360061	MANUFACTURE(10702-005)