{"active_ingredient":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 12.5 mg Antihistamine"],"active_ingredient_table":["
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 12.5 mg Antihistamine
"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours do not take more than 8 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage"],"dosage_and_administration_table":["
adults and children 12 years and over take 2 caplets every 6 hours do not take more than 8 caplets in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
"],"effective_time":"20191014","id":"7e5d073a-e80d-37c5-e053-2a91aa0a4f89","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin"],"indications_and_usage":["Uses temporarily relieves: runny nose sneezing itching of the nose or throat and itchy, watery eyes due to hay fever headache minor aches and pains"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton NDC 57344-101-01 RESTORE u † COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® SEVERE ALLERGY MAY CAUSE DROWSINESS Severe Allergy Pain Reliever, Antihistamine Runny Nose Sneezing Itchy, Watery Eyes Diphenhydramine HCl Sinus Pain - Acetaminophen 24 CAPLETS PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 12.5 mg Antihistamine"],"purpose_table":["
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 12.5 mg Antihistamine
"],"set_id":"01527b35-81e6-4742-93d7-fa51f574dd25","spl_product_data_elements":["Acetaminophen, Diphenhydramine Hydrochloride ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL PROPYLPARABEN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AAA;1094"],"spl_unclassified_section":["Drug Facts","Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048"],"stop_use":["Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20º-25ºC (68º-77ºF) in a dry place retain carton for complete product information"],"version":"2","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin 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 Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"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"]}