{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Adult Allergy Relief CalmCo Allergy Relief PROPYLENE GLYCOL SUCROSE CORN SYRUP NEOTAME SODIUM CHLORIDE SUCRALOSE STARCH, CORN MALTITOL GLYCERYL MONO AND DIPALMITOSTEARATE HYDROXYPROPYL BETADEX ACACIA WATER FD&C RED NO. 40 POLYETHYLENE GLYCOL 400 POVIDONE K30 CARRAGEENAN TRISODIUM CITRATE DIHYDRATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active Ingredient and Purpose Active Ingredient and Purpose Active ingredient Purpose Diphenhydramine HCl 25 mg................. Anthistamine" ], "active_ingredient_table": [ "
Active ingredientPurpose
Diphenhydramine HCl 25 mg.................Anthistamine
" ], "purpose": [ "Active ingredient Purpose Diphenhydramine HCl 25 mg................. Anthistamine" ], "purpose_table": [ "
Active ingredientPurpose
Diphenhydramine HCl 25 mg.................Anthistamine
" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat • temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing" ], "warnings": [ "Warnings Do not use • To make child sleepy • with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product • marked 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 (1-800-222-1222) right away." ], "do_not_use": [ "Do not use • To make child sleepy • with any other product containing diphenhydramine, even one used on skin" ], "ask_doctor": [ "ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "when_using": [ "when using this product • marked 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" ], "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." ], "other_safety_information": [ "Other Information • each piece: contains sodium 9 mg . low sodium • store in a cool dry place between 20-25°C (68-77°F). • Child Resistant Container ; do not use if printed seal under cap is broken or missing." ], "inactive_ingredient": [ "Inactive Ingredients FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract ( carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate." ], "dosage_and_administration": [ "Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours chew each piece thoroughly before swallowing Age (Yrs) Dose ( per piece) adults and children 12 years and over 1 to 2 pieces (25mg to 50 mg) children under 12 years do not use" ], "dosage_and_administration_table": [ "
Age (Yrs)Dose ( per piece)
adults and children 12 years and over1 to 2 pieces (25mg to 50 mg)
children under 12 yearsdo not use
" ], "questions": [ "Questions or Comments? Call 941-203-4590 or visit calmco.com" ], "package_label_principal_display_panel": [ "Principal Display Panel PDP Dr Kids A LABEL Dr Kids A" ], "set_id": "08288825-0f38-b6a3-e063-6394a90aa358", "id": "28b5f975-0f0c-dec2-e063-6394a90ac916", "effective_time": "20241207", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Adult Allergy Relief" ], "generic_name": [ "CALMCO ALLERGY RELIEF" ], "manufacturer_name": [ "CalmCo" ], "product_ndc": [ "73282-2520" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "2046528" ], "spl_id": [ "28b5f975-0f0c-dec2-e063-6394a90ac916" ], "spl_set_id": [ "08288825-0f38-b6a3-e063-6394a90aa358" ], "package_ndc": [ "73282-2520-1" ], "is_original_packager": [ true ], "upc": [ "0313992000904" ], "unii": [ "TC2D6JAD40" ] } } ] }