{"active_ingredient":["Active ingredient (in each capsule) Diphenhydramine HCl 25 mg"],"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"],"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, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"66.200%\" align=\"left\"/> <col width=\"33.800%\" align=\"left\"/> <tbody> <tr> <td align=\"left\" valign=\"bottom\" styleCode=\"Toprule Botrule Rrule\">adults and children 12 years and over </td> <td align=\"left\" valign=\"bottom\" styleCode=\"Toprule Botrule\">1 to 2 capsules </td> </tr> <tr> <td align=\"left\" valign=\"top\" styleCode=\"Botrule Rrule\">children 6 to under 12 years </td> <td align=\"left\" valign=\"top\" styleCode=\"Botrule\">1 capsule </td> </tr> <tr> <td align=\"left\" valign=\"top\" styleCode=\"Botrule Rrule\">children under 6 years </td> <td align=\"left\" valign=\"top\" styleCode=\"Botrule\">do not use </td> </tr> </tbody> </table>"],"effective_time":"20200127","id":"89099217-6a54-40a1-bfce-8bb6bc55ca5c","inactive_ingredient":["Inactive ingredients benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing"],"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":{},"other_safety_information":["Other information each capsule contains: calcium 20 mg store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light"],"package_label_principal_display_panel":["Principal Display Panel - 25 mg Pouch Label Safetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc. Buffalo NY 14215 Allergy Relief Diphenhydramine HCl antihistamine 2 Capsules Principal Display Panel - 25 mg Pouch Label","Principal Display Panel – 50 Pouches Carton Label Safetec ® of America, Inc. *Compare to the active ingredient in Benadryl ® NDC 61010-4409-1 Allergy Relief Diphenhydramine HCl 25 mg PUSH TO OPEN Dispense through opening Antihistamine Itchy Watery Eyes Sneezing Runny Nose TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 50 Pouches 2 Capsules per pouch Graphic-Untitled Principal Display Panel – 50 Pouches Carton Label","Principal Display Panel – 100 Pouches Carton Label Safetec ® of America, Inc. *Compare to the active ingredient in Benadryl ® NDC 61010-4409-2 Allergy Relief Diphenhydramine HCl 25 mg – Antihistamine Itchy Watery Eyes Sneezing Runny Nose PUSH TO OPEN Dispense through opening TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 100 Pouches 2 Capsules per pouch Principal Display Panel – 100 Pouches Carton Label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call toll free: 1-800-456-7077"],"set_id":"ef6b86cc-bfc5-4e74-a806-33de9a68ce45","spl_product_data_elements":["Diphenhydramine Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine benzyl alcohol butylparaben D&C red NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE PINK WHITE OVAL AP;20"],"spl_unclassified_section":["Drug Facts"],"version":"2","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 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 right away. (1-800-222-1222)"],"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 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)"]}