{"active_ingredient":["Active ingredient (in each chewable tablet) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["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"],"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 find right dose on chart below chew or crush tablets completely before swallowing; do not swallow tablets whole take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)"],"dosage_and_administration_table":["
Age (yr)Dose (chewable tablets)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)
"],"effective_time":"20251027","id":"aa592608-361f-4c44-aba4-99e6ceb1df7f","inactive_ingredient":["Inactive ingredients dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Allergies MY CHILD NEEDS HELP WITH"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Unconditional Love"],"package_ndc":["73418-747-09"],"product_ndc":["73418-747"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049900"],"spl_id":["aa592608-361f-4c44-aba4-99e6ceb1df7f"],"spl_set_id":["5ad293e9-0a4b-4923-8a91-f01450726828"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0810007183145"]},"package_label_principal_display_panel":["Principal display panel TINY WELLNESS CO 6 YEARS & OLDER Natural Flavor Dye Free MY CHILD NEEDS HELP WITH: Allergies DIPHENHYDRAMINE HCl, 12.5 mg Chewable Tablets / Antihistamine 4-6 Hour Dose Relief for runny nose, sneezing, itchy watery eyes, itchy throat or nose. Chew or crush tablets completely before swallowing. 20 chewable tablets NATURAL GRAPE FLAVOR TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by: Tiny Wellness Co. Los Angeles, CA 90272 Questions? Call and ask at (888) 860-6888 50844 ORG091974709 Tiny Wellness 44-747 Tiny Wellness 44-747"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-(888) 860-6888"],"set_id":"5ad293e9-0a4b-4923-8a91-f01450726828","spl_product_data_elements":["Allergies MY CHILD NEEDS HELP WITH Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE DEXTROSE MONOHYDRATE ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL STEARIC ACID SUCRALOSE natural 44;747"],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number"],"version":"9","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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages 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 (1-800-222-1222) right away."],"when_using":["When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages excitability may occur, especially in children"]}