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Dexbrompheniramine Maleate 6 Mg and Pseudoephedrine Sulfate 120 Mg Extended-Release Tablets

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Dexbrompheniramine Maleate 6 Mg and Pseudoephedrine Sulfate 120 Mg Extended-Release Tablets Newtown, PA 18940 MADE IN USA IN MADE 18940 PA Newtown, Newtown, PA 18940 U.S.A. 18940 PA Newtown, 6014/03 6014/00 Manufactured by KVK-TECH, INC KVK-TECH, by Manufactured Manufactured by KVK-TECH, INC., KVK-TECH, by Manufactured COLD & ALLERGY & COLD carton COLD, ALLERGY & DECONGESTANT & ALLERGY COLD, D recyclable CA Extended-release Tablets Extended-release and Pseudoephedrine Sulfate 120 mg 120 Sulfate Pseudoephedrine and ® Dexbrompheniramine Maleate 6 mg 6 Maleate Dexbrompheniramine 20 EXTENDED-RELEASE TABLETS EXTENDED-RELEASE EXP.: LOT: parahydroxy benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, pregelatinized starch, propyl lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, aluminum lake, FD&C blue No. 1 yellow 6 gelatin, hypromellose, Inactive ingredients Drug Facts Questions? Runny Nose, Sneezing Nose, Runny Call 1-215-579-1842 (continued) tion - Conges Sinus & Nasal calcium sulfate, carnauba wax, colloidal silicon dioxide, D&C yellow No. 10 Maximum Maximum CA Dexbrompheniramine Maleate 6 mg and Pseudoephedrine Sulfate 120 mg Extended-release Tablets COLD & ALLERGY & COLD NASAL DECONGESTANT-Pseudoephedrine NASAL COLD & ALLERGY Dexbrompheniramine ANTIHISTAMINE- Antihistamine/Nasal Decongestant Antihistamine/Nasal - D DECAAAAAAAAAAAAAAA & ALLERGY COLD, D CA Extended-release Tablets Extended-release ® and Pseudoephedrine Sulfate 120 mg 120 Sulfate Pseudoephedrine and maize Relief Sustained Hour ® 2 1 Dexbrompheniramine Maleate 6 mg 6 Maleate Dexbrompheniramine PSEUDOEPHEDRINE SULFATE... 120 mg IS TORN OR MISSING OR TORN IS mg 120 SULFATE... PSEUDOEPHEDRINE IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE... 6 mg AND AND mg 6 MALEATE... DEXBROMPHENIRAMINE WITH IMPRINTED IS TORN OR MISSING. OR TORN IS COLD & ALLERGY & COLD Relief COLD, ALLERGY & DECONGESTANT & ALLERGY COLD, Sustained SAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD CARD BLISTER ON BACKING IF USE NOT DO SEALED: SAFETY D ALLERGY & DECONGESTANT DECONGESTANT & ALLERGY CA Extended-release Tablets Extended-release Hour IMPRINTED WITH CAD WITH IMPRINTED COLD, COLD, ® 2 1 120 mg 120 and Pseudoephedrine Sulfate Pseudoephedrine and IF BACKING ON BLISTER CARD CARD BLISTER ON BACKING IF ® SAFETY SEALED: DO NOT USE USE NOT DO SEALED: SAFETY 6 mg 6 Dexbrompheniramine Maleate Dexbrompheniramine Dexbrompheniramine ®Maleate 6 mg Drug Facts (continued) and Pseudoephedrine Sulfate 120 mg Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis Extended-release Tablets glaucoma heart disease high blood pressure thyroid disease CAD COLD,COLD ALLERGY & ALLERGY & DECONGESTANT diabetes trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or Drug Facts tranquilizers Active ingredients (in each tablet) Purpose When using this product do not use more than directed▀▀▀▀▀▀▀▀▀▀▀ Dexbrompheniramine maleate 6 mg ........................... Antihistamine excitability may occur, especially in children Pseudoephedrine sulfate 120 mg ......................... Nasal decongestant drowsiness may occur avoid alcoholic beverages Uses alcohol, sedatives and tranquilizers may increase drowsiness temporarily relieves nasal congestion due to the common cold, use caution when driving a motor vehicle or operating machinery hay fever or other upper respiratory allergies, and associated Stop use and ask a doctor if with sinusitis nervousness, dizziness or sleeplessness occur helps decongest sinus openings and sinus passages symptoms do not improve within 7 days or occur with a reduces swelling of nasal passages, shrinks swollen membranes, feverYou may report side effects to FDA at 1-800-FDA 1088 and temporarily restores freer breathing through the nose If pregnant or breast-feeding, ask a health professional before use. temporarily alleviates the following symptoms due to hay fever Keep out of reach of children. In case of overdose, get medical help (allergic rhinitis): or contact a Poison Control Center right away. runny nose sneezing itching of the nose or throat itchy and watery eyes Directions adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. Warnings children under 12 years of age: ask a doctor Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, Other information each tablet contains: calcium 69 mg psychiatric or emotional conditions, or Parkinson’s disease), store between 2 0 � to 2calcium5�C with 69 mg and or for 2 weeks after stopping the MAOI drug. If you do not know sodiumexcursions 0 mg permitted between (68° to 77°F) if your prescription drug contains an MAOI, ask a doctor or 15� to 30�C (59� to 86�F)[see USP pharmacist before taking this product. Controlled Room Temperature]. Version# 1 4-25-06 5-1-06 *ALL COLORS CREATE 11-14-06 4/CPRO FROM 4/C PROCESS 11-27-06 11-27-06(2) KVK TECH CAD KVK5110620 xxxx xxx PO#xxx Drug Facts (continued) Uses Inactive Ingredients: Questions? Call 1-215-579-1842. 2 . 1088 - FDA - 800 - Dexbrompheniramine Maleate 6 mg 1 and Pseudoephedrine Sulfate 120 mg Extended-release Tablets Antihistamine/ Nasal Decongestant COLD & ALLERGY LOT: DO NOT USE. PUSH TABLET THROUGH BACKING THROUGH TABLET PUSH USE. NOT DO Manufactured By: EXP: , KVK-TECH, INC. Contains FD&C No. 6. Yellow Newtown, PA 18940 USA 6126/02 MADE IN USA Call your doctor for medical advice about side effects. side about advice medical for your doctor Call at FDA to effects side may report You IF BACKING HAS BEEN TORN --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- ROBERT L WEST 02/27/2013 Deputy Director, Office of Generic Drugs, for Gregory P. Geba, M.D., M.P.H. Reference ID: 3267870.
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