{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "spl_product_data_elements": [ "Childrens Cold and Allergy Brompheniramine maleate, Phenylephrine HCl BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE ANHYDROUS CITRIC ACID" ], "active_ingredient": [ "Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Phenylephrine HCI 5 mg" ], "purpose": [ "Purposes Antihistamine Nasal decongestant" ], "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 itchy, watery eyes sneezing itching of the nose or throat temporarily restores freer breathing through the nose ​​​" ], "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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema 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 nervousness, dizziness or sleeplessness occur 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 (1-800-222-1222) right away." ], "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." ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema 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" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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 (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over20 mL every 4 hours
children 6 to 11 years 10 mL every 4 hours
children under 6 yearsdo not use
" ], "storage_and_handling": [ "Other information each 10 mL contains : sodium 6 mg store between 20-25°C (68-77°F). Do not refrigerate." ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate" ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredients in Childreb's Dimetapp® Cold & Allergy** Children's Dibromm Cold & Allergy Brompheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant For relief of: Itchy, watery eyes Runny Nose Sneezing Stuffy nose Itching of the nose or throat For ages 6 years and over Alcohol-free Grape Flavor Dosing Cup Included FL OZ (mL) **This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC. KANSAS CITY, KANSAS 66106", "Package Label BEST CHOICE Children's Cold & Allergy Brompheniramine maleate 2 mg, Phenylephrine HCl 5 mg" ], "set_id": "042f9449-4af0-4b15-bb3e-236afeb1e11f", "id": "5d89ed48-9728-4c13-af57-a41540c77f8c", "effective_time": "20260305", "version": "8", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Childrens Cold and Allergy" ], "generic_name": [ "BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "Best Choice (Valu Merchandisers Company)" ], "product_ndc": [ "63941-012" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BROMPHENIRAMINE MALEATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1053258" ], "spl_id": [ "5d89ed48-9728-4c13-af57-a41540c77f8c" ], "spl_set_id": [ "042f9449-4af0-4b15-bb3e-236afeb1e11f" ], "package_ndc": [ "63941-012-04" ], "is_original_packager": [ true ], "upc": [ "0070038612636" ], "unii": [ "IXA7C9ZN03", "04JA59TNSJ" ] } } ] }