{"active_ingredient":["Active Ingredients (in each 10 mL) Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, asthma, or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ▪ taking any other oral nasal decongestant or stimulant ▪ taking sedatives or tranquilizers"],"do_not_use":["Do not use ▪ to sedate a child or to make a child sleepy ▪ if you are now taking a prescription monoamine oxidase 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."],"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 width=\"100%\"><col width=\"38%\"/><col width=\"45%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">age</content></th><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">Dose</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule \" valign=\"middle\"><paragraph>adults and children 12 years and over </paragraph></td><td align=\"center\" styleCode=\"Rrule Toprule Botrule \" valign=\"middle\"><paragraph>20 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>10 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"middle\"><paragraph>children under 6 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260814","id":"d18da9b4-420f-4d03-ae56-af2bcb690960","inactive_ingredient":["INACTIVE INGREDIENTS anhydrous 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies ▪ temporarily relieves these symptoms due to hay fever (allergic rhinitis): ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat ▪ temporarily restores freer breathing through the nose"],"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 Childrens Cold and Allergy"],"generic_name":["BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY, INC."],"package_ndc":["69842-639-04"],"product_ndc":["69842-639"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1053258"],"spl_id":["d18da9b4-420f-4d03-ae56-af2bcb690960"],"spl_set_id":["f4020c08-29f6-4609-834e-191ce6885130"],"substance_name":["BROMPHENIRAMINE MALEATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["IXA7C9ZN03","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy* NDC# 69842-639-04 Children's Cold & Allergy Brompheniramine Maleate USP (Antihistamine) Phenylephrine HCl USP (Nasal Decongestant) • Stuffy Nose • Runny Nose • Sneezing • Itchy, Watery Eyes Alcohol-Free • Sugar Free Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored 4 FL OZ (118 ml) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com 1-800-SHOP CVS V12431 CVS Quality Money Back Guaranteed *This product is not manufactured or distributed by Pfizer, the distributor of Children’s Dimetapp® Cold & Allergy. CVS Childrens Cold and Allergy Relief Dimetapp"],"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 Nasal Decongestant"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"f4020c08-29f6-4609-834e-191ce6885130","spl_product_data_elements":["CVS Childrens Cold and Allergy Brompheniramine maleate, Phenylephrine HCl BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE 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"],"stop_use":["Stop use and ask a doctor if ▪ you get nervous, dizzy, or sleepless ▪ symptoms do not get better within 7 days or are accompanied by fever"],"version":"7","warnings":["WARNINGS Do not use ▪ to sedate a child or to make a child sleepy ▪ if you are now taking a prescription monoamine oxidase 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, asthma, or chronic bronchitis Ask a doctor or pharmacist before use if you are ▪ taking any other oral nasal decongestant or stimulant ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ drowsiness may occur ▪ avoid alcoholic beverages ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children Stop use and ask a doctor if ▪ you get nervous, dizzy, or sleepless ▪ symptoms do not get better within 7 days or are accompanied by fever 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 beverages ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children"]}