{"active_ingredient":["Drug Facts Active ingredient (in each caplet) Acetaminophen ..............................500 mg Diphenhydramine HCl ......................25 mg"],"ask_doctor":["Ask a doctor before use if you have ■ liver disease; ■ a breathing problem such as emphysema or chronic bronchitis; ■ trouble urinating due to an enlarged prostate gland; ■ glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin; ■ taking sedatives or tranquilizers"],"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 product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions: do not take more than directed (see overdose warning) adults and children 12 years and over 2 caplets at bedtime do not take more than 2 caplets of this product 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 2 caplets at bedtime do not take more than 2 caplets of this product 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":"20110328","id":"bbaaa8bb-d389-4ce2-ad82-d805ec281f72","inactive_ingredient":["Inactive Ingredients Carnauba wax, FD&C blue # 1 al lake, FD&C blue # 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin"],"indications_and_usage":["Indicated for pain relief and night time sleep aid."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"overdosage":["Overdasage Warnings; Taking more than the recommended dose (overdose) may liver damage. In case of overdose, get medical help or contact poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["ACETAMINOPHEN AND DIPHENHYDRAMINE HCl CAPLETS 500 mg and 25 mg, Bulk"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Pain Reliver Nighttime Sleep Aid"],"set_id":"bbaaa8bb-d389-4ce2-ad82-d805ec281f72","spl_product_data_elements":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE CARNAUBA WAX FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN Blue CAPSULE C;24"],"spl_unclassified_section":["*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® PM Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512"],"stop_use":["Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur These could be signs of a serious condition."],"storage_and_handling":["Other Information store between 20°- 25°C (68°- 77°F) do not use if the box is opened"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take; ■ more than 4,000 mg of acetaminophen in 24 hours; ■ with other drugs containing acetaminophen; ■ 3 or more alcoholic drinks everyday 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 product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease; ■ a breathing problem such as emphysema or chronic bronchitis; ■ trouble urinating due to an enlarged prostate gland; ■ glaucoma Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin; ■ taking sedatives or tranquilizers When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery. Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur These could be signs of a serious condition. Indicated for pain relief and night time sleep aid. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."],"when_using":["Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness","When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery."]}