{"active_ingredient":["Active ingredient (in each capsule) Diphenhydramine Hydrochloride 25 mg Diphenhydramine Hydrochloride 50 mg"],"dosage_and_administration":["Directions • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours. • Children 12 years and under: Consult a Doctor"],"effective_time":"20181023","id":"419f717e-45ed-4cb5-9d35-a6d43058cd70","inactive_ingredient":["Inactive ingredients Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose and sneezing • itching of the nose or throat • itchy, watery eyes."],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Package Label - Principal Display Panel NDC 0185-0648-30 DiphenhydrAMINE Hydrochloride Capsules USP 25 mg 30 Capsules Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Product of Japan Sandoz 25 mg x 30 Capsules","Package Label - Principal Display Panel NDC 0185-0649-30 DiphenhydrAMINE Hydrochloride Capsules USP 50 mg 30 Capsules Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Product of Japan Sandoz 50 mg x 30 Capsules"],"purpose":["Purpose Antihistamine"],"set_id":"aab7ad3c-858e-4289-b0ad-626d0a73c580","spl_product_data_elements":["diphenhydramine hydrochloride diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE STARCH, CORN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE SODIUM LAURYL SULFATE pink top/clear body E648 diphenhydramine hydrochloride diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE STARCH, CORN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE SODIUM LAURYL SULFATE pink top/pink body E649"],"storage_and_handling":["Storage and Handling Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 L1812 Rev. 11/08"],"version":"13","warnings":["Warnings Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland Do not use with any other product containing diphenhydramine, including products used topically. Ask a doctor or pharmacist before use if you are • taking tranquilizers or sedatives • taking other products containing diphenhydramine When using this product • Do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • use caution when driving a motor vehicle or operating machinery If pregnant or breastfeeding ask a health professional before use."]}