{"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":"20120605","how_supplied":["HOW SUPPLIED DiphenhydrAMINE Hydrochloride Capsules USP 50 mg Bottles of 30 NDC 54868-1050-1 Bottles of 100 NDC 54868-1050-5"],"how_supplied_table":["<table width=\"30%\" ID=\"i827ff783-2a5c-4fe3-8466-2e4d5b006709\"> <tbody> <tr> <td>Bottles of 30  </td> <td>NDC 54868-1050-1  </td> </tr> <tr> <td>Bottles of 100  </td> <td>NDC 54868-1050-5  </td> </tr> </tbody> </table>"],"id":"3144133b-0993-4e96-b5c1-78a79dbad72b","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 54868-1050-1 DiphenhydrAMINE Hydrochloride Capsules USP 50 mg 30 Capsules 50 mg x 30 Capsules - Label"],"purpose":["Purpose Antihistamine"],"set_id":"8975a041-76dd-4c5e-aa83-e1021d55a084","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 ANHYDROUS LACTOSE MAGNESIUM STEARATE SILICON DIOXIDE 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 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146"],"version":"1","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 ny 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."]}