{"active_ingredient":["Active Ingredient (in each banded capsule) Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg"],"ask_doctor":["Ask a doctor before use if you have 25 MG • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland 50 MG • glaucoma • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"dosage_and_administration":["Directions • Take every 4-6 hours • Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package."],"dosage_and_administration_table":["
adults and children 12 years of age and over
1 to 2 capsules
children 6 years to under 12 years of age
1 capsule
children under 6 years of age
do not use this product in children under 6 years of age
","
adults and children 12 years of age and over
1 capsule
children 6 years to under 12 years of age
Ask a doctor, the proper dosage strength is not available in this package**
"],"effective_time":"20260423","id":"18963d5d-f81a-4e06-95e5-44ee4ea95ce2","inactive_ingredient":["Inactive Ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch."],"indications_and_usage":["Use 25 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itchy throat and nose • Temporarily relieves these symptoms due to the common cold: o runny nose o sneezing 50 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold o sneezing o runny nose o itchy, watery eyes o itchy throat and nose"],"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."],"openfda":{"application_number":["M012"],"brand_name":["Diphenhydramine HCl"],"generic_name":["DIPHENHYDRAMINE HCL"],"manufacturer_name":["Cardinal Health 107, LLC"],"original_packager_product_ndc":["0904-2056"],"package_ndc":["55154-0661-0"],"product_ndc":["55154-0661"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["18963d5d-f81a-4e06-95e5-44ee4ea95ce2"],"spl_set_id":["abc0e348-8532-4658-bd8c-d7dbe5a28c7d"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0055154066105"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-0661-0 DIPHENHYDRAMINE HCl CAPSULES 50 mg 10 CAPSULES 50mg bag label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? Questions or comments? (800) 616-2471"],"set_id":"abc0e348-8532-4658-bd8c-d7dbe5a28c7d","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE, UNSPECIFIED FORM STARCH, CORN red center band CPC;836"],"spl_unclassified_section":["Other Information • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] • Protect from moisture • Contains lactose","Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 Overbagged with 10 capsules per bag, NDC 55154-0661-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L32991870524 M-29 Rev. 10/16 4568-10-16 Re-Order No. 008237 M-29 Rev. 10/16 4570-10-16 Re-Order No. 008239 M-29 Rev. 03/23 Re-Order No. 301575"],"spl_unclassified_section_table":["
M-29
Rev. 10/16
4568-10-16
Re-Order No. 008237
M-29
Rev. 10/16
4570-10-16
Re-Order No. 008239
M-29
Rev. 03/23
Re-Order No. 301575
"],"version":"16","warnings":["WARNINGS Do not use 25 MG • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin 50 MG • to make a child sleepy • with any other product containing diphenhydramine, including one applied topically"],"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"]}