{"active_ingredient":["Active Ingredients (in each 10 mL) Brompheniramine maleate, USP 2 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, or chronic bronchitis."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers"],"do_not_use":["Do not use ▪ to sedate a child or to make a child sleepy"],"dosage_and_administration":["Directions ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosage cup provided ▪ keep dosage cup with product ▪ ml = milliliter age Dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use"],"dosage_and_administration_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"40%\"/><col width=\"43%\"/><thead><tr><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">age</content></th><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">Dose</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>adults and children 12 years and over </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>20 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>10 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>children under 6 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260814","id":"7496b83a-c499-46ff-8e48-bd1fe1ddf876","inactive_ingredient":["Inactive ingredients citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose"],"indications_and_usage":["Uses ▪ temporarily relieves: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes due to hay fever ▪ itching of the nose or throat"],"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 at 1-800-222-1222."],"openfda":{"application_number":["M012"],"brand_name":["CVS PHARMACY Childrens Cold and Allergy"],"generic_name":["BROMPHENIRAMINE MALEATE"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY, INC."],"package_ndc":["51316-693-04"],"product_ndc":["51316-693"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2685263"],"spl_id":["7496b83a-c499-46ff-8e48-bd1fe1ddf876"],"spl_set_id":["004e104b-d6ff-48d5-8685-cd1bff45399a"],"substance_name":["BROMPHENIRAMINE MALEATE"],"unii":["IXA7C9ZN03"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy* NDC# 51316-693-04 Children's Cold & Allergy Brompheniramine Maleate USP (Antihistamine) Relieves + comforts: • Runny Nose • Itchy, Watery Eyes • Sneezing • Itchy throat For Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored No Added Alcohol No Added Sugar 4 FL OZ (118 ml) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: *This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Allergy. CVS Childrens Cold and Allergy Relief 4 FL OZ 118 ml"],"package_label_principal_display_panel_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">IMPORTANT: </content>Keep this carton for future reference on full labeling.</paragraph></td></tr></tbody></table>"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Antihistamine"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"004e104b-d6ff-48d5-8685-cd1bff45399a","spl_product_data_elements":["CVS PHARMACY Childrens Cold and Allergy Brompheniramine maleate BROMPHENIRAMINE MALEATE BROMPHENIRAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE purple liquid"],"spl_unclassified_section":["Drug Facts","Other information ▪ each 10 ml contains: sodium 6 mg ▪ store at room temperature"],"version":"3","warnings":["Warnings Do not use ▪ to sedate a child or to make a child sleepy Ask a doctor before use if you have ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, or chronic bronchitis. Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ drowsiness may occur ▪ avoid alcoholic drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children 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 at 1-800-222-1222."],"when_using":["When using this product ▪ do not use more than directed ▪ drowsiness may occur ▪ avoid alcoholic drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children"]}