{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a sodium-restricted diet"],"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 make a child sleepy with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours use only with enclosed dose cup. Do not use with any other device mL = milliliter Adults and children 12 years of age and over 10 mL-20 mL (25 mg to 50 mg) Children 6 to 12 years of age 5 mL- 10 mL (12.5 mg to 25 mg) Children 2 to 5 years of age Do not use unless directed by a doctor Children under 2 years of age Do not use"],"dosage_and_administration_table":["
Adults and children 12 years of age and over 10 mL-20 mL (25 mg to 50 mg)
Children 6 to 12 years of age 5 mL- 10 mL (12.5 mg to 25 mg)
Children 2 to 5 years of age Do not use unless directed by a doctor
Children under 2 years of age Do not use
"],"effective_time":"20190925","id":"93647dad-3daf-f7c5-e053-2995a90a2974","inactive_ingredient":["Inactive ingredients artificial cherry flavor, citric acid, D&C red #33, FD&C red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution."],"indications_and_usage":["Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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. (1-800-222-1222)"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label Rugby ® NDC 0536-0770-97 ALCOHOL-FREE ALLERGY MEDICATION Diphenhist ® ORAL SOLUTION (Diphenhydramine HCl, USP) Antihistamine For Temporary Relief of Symptoms of Upper Respiratory Allergies and Hay Fever 4 fl oz (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"92fc0a85-924b-4f7b-a83c-27c56dac3014","spl_product_data_elements":["Diphenhist Diphenhydramine Hydrochloride ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN POLYSORBATE 20 WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Drug Facts","Distributed By: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152"],"storage_and_handling":["Other information each 5 mL contains: sodium 7 mg store at room temperature 20°-25°C (68°-77°F)"],"version":"5","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness use caution 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. (1-800-222-1222)"],"when_using":["When using this product avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}