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NDC 10702-0005-03 Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6; 120 mg/1; mg/1 Details

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6; 120 mg/1; mg/1

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by KVK-TECH, INC.. The primary component is DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE.

MedlinePlus Drug Summary

Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 10702-0005-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine

Product Information

NDC	10702-0005
Product ID	10702-005_838e40fd-bd38-4b8d-abd4-45da435f1777
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dexbrompherniramine Maleate and Pseudoephedrine Sulfate
Proprietary Name Suffix	6mg/120mg
Non-Proprietary Name	Dexbrompherniramine Maleate and Pseudoephedrine Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	6; 120
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Labeler Name	KVK-TECH, INC.
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078648
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10702-0005-03 (10702000503)

Pricing Information	N/A
NDC Package Code	10702-005-03
Billing NDC	10702000503
Package	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03)
Marketing Start Date	2018-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078648	12/17/2018

Labeler - KVK-TECH, INC. (173360061)

Registrant - AVANTHI (832316694)

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

Revised: 12/2017

Document Id: 838e40fd-bd38-4b8d-abd4-45da435f1777

Set id: cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4

Version: 4

Effective Time: 20171204

Search by Drug Name or NDC

NDC 10702-0005-03 Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6; 120 mg/1; mg/1 Details

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6; 120 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 10702-0005-03 (10702000503)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4 Details

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT (IN EACH TABLET)

PURPOSE

USES

WARNINGS

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

IF PREGNANT OR BREAST-FEEDING

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

PRODUCT PACKAGING

Principal Display Panel

INGREDIENTS AND APPEARANCE

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