Label: DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG- dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 10702-005-03, 10702-005-21
- Packager: KVK-TECH, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 4, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT (IN EACH TABLET)
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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
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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
- 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
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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
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Principal Display Panel
Carton Label
Dexbrompheniramine Maleate 6 mg
and Pseudoephedrine Sulfate 120 mg
Extended-release TabletsAntihistamine/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 TabletsAntihistamine/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.
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INGREDIENTS AND APPEARANCE
DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG
dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended releaseProduct 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)