{"active_ingredient":["ACTIVE INGREDIENT (IN EACH TABLET) Dexbrompheniramine maleate 6 mg Pseudoephedrine Sulfate 120 mg"],"ask_doctor":["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_or_pharmacist":["ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE taking sedative or tranquilizers"],"dosage_and_administration":["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"],"effective_time":"20251111","id":"43557417-acc5-3e0e-e063-6294a90aaaaa","inactive_ingredient":["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"],"indications_and_usage":["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"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["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 Eyes 12 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 Congestion unny Nose, Sneezing Itchy, Watery Eyes12 Hour Sustained Relief 30 EXTENDED-RELEASE TABLETS DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING. carton label container Label"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING ask a health professional before use."],"purpose":["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"],"set_id":"cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4","spl_product_data_elements":["Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 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 DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE K;5"],"spl_unclassified_section":["DRUG FACTS"],"stop_use":["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"],"version":"5","warnings":["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."]}