{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen 500 mg Dexbrompheniramine maleate 2mg"],"dosage_and_administration":["Directions : adults and children 12 years of age and older take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. children under 12 years of age consult a doctor"],"dosage_and_administration_table":["<table width=\"40%\"><caption/><tbody><tr><td styleCode=\"Botrule Lrule\">adults and children 12 years of age and older</td><td styleCode=\"Lrule Toprule\">take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. </td></tr><tr><td styleCode=\"Botrule Lrule\">children under 12 years of age</td><td styleCode=\"Lrule Toprule\">consult a doctor</td></tr></tbody></table>"],"effective_time":"20251205","id":"cb33b7c4-d41e-450e-b731-77fc4f8e1720","inactive_ingredient":["Inactive ingredients: magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid"],"indications_and_usage":["Uses • for the temporary relief of minor aches and pains associated with • headache • the common cold • toothache • muscular aches • backache • premenstrual and menstrual cramps • the minor pain from arthritis and reduces fever. • for the temporary relief of • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever."],"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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["G-DOLOGEN"],"generic_name":["ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"package_ndc":["52083-683-90"],"product_ndc":["52083-683"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2729424"],"spl_id":["cb33b7c4-d41e-450e-b731-77fc4f8e1720"],"spl_set_id":["7a4e1d64-2510-405f-a1dc-e02a803b6fbd"],"substance_name":["ACETAMINOPHEN","DEXBROMPHENIRAMINE MALEATE"],"unii":["362O9ITL9D","BPA9UT29BS"],"upc":["0352083683909"]},"package_label_principal_display_panel":["Packaging G-DOLOGEN"],"purpose":["Purpose Pain reliever/fever reducer Antihistamine"],"questions":["Questions or comments? 1-787-767-2072 Call weekdays from 8:00 am to 4.00 pm AST. You may also report serious side effects to this phone number."],"set_id":"7a4e1d64-2510-405f-a1dc-e02a803b6fbd","spl_product_data_elements":["G-DOLOGEN Acetaminophen, Dexbrompheniramine maleate ACETAMINOPHEN ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID D"],"spl_unclassified_section":["Drug Facts","Compare to Dologen ® Sugar & Dye Free Manufactured for: Kramer Novis San Juan, PR 00917 Made in USA with imported ingredients www.kramernovis.com Peel the label from the bottom right corner for Drug Facts (continued)."],"storage_and_handling":["Other information: • tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you are allergic to acetaminophen or any of the inactive ingredients in the product • this product unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostrate gland • if you are taking sedatives or tranquilizers, without first consulting your doctor. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. • use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}