{"active_ingredient":["Active ingredients (in each Caplet) Purpose Acetaminophen 500 mg Pain reliever/ fever reducer Diphenhydramine HCL 25 mg Sleep Aid"],"active_ingredient_table":["
Active ingredients (in each Caplet) Purpose
Acetaminophen 500 mg Pain reliever/ fever reducer
Diphenhydramine HCL 25 mg Sleep Aid
"],"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 pharmacists before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use * with any other product containing acetaminophen * with any other product containing diphenhydramine, even one used on skin * in children under 12 years of age"],"dosage_and_administration":["Direction * use as directed * adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor * 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 could cause serious health problems."],"effective_time":"20100615","id":"13d391cd-6737-4d5d-a811-4cd602ec0013","inactive_ingredient":["Inactive ingredients croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1"],"indications_and_usage":["Uses Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS Each Film coated Tablet Contains: ACETAMEINOPHEN 500 mg DIPHENHYDRAMINE HCL 25 mg Lot No : MFG. DATE : Exp. Date : Jar No. : Quantity : 31000 Tablets NDC. No : 65437-041-31 WARNING : KEEP OUT OF THE REACH OF CHILDREN STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER MANUFACTURED BY: MANUFACTURED CODE No Guj/Drugs/G/1362 LABELER CODE # 14803 MANUFACTURED FOR: HIMPRIT PHARMACHEM PVT. LTD \"LAKULISH\", R.V.DESAI ROAD, NEXT TO NAVAPURA POLICE STATION BARODA, INDIA – 390 001 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label"],"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/ fever reducer Diphenhydramine HCL 25 mg Sleep Aid"],"purpose_table":["
Active ingredients (in each Caplet) Purpose
Acetaminophen 500 mg Pain reliever/ fever reducer
Diphenhydramine HCL 25 mg Sleep Aid
"],"set_id":"6a2c1efb-d91b-48d2-b623-aa941e2c6f0e","spl_product_data_elements":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SODIUM METABISULFITE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STEARIC ACID POLYETHYLENE GLYCOL FD&C BLUE NO. 1 TITANIUM DIOXIDE WATER SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE TALC Capsule Shaped"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if * sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness * new symptoms occur * redness or swelling is present * pain gets worse or lasts more than 10 days * fever gets worse or lasts more than 3 days"],"storage_and_handling":["Other information * Store at room temperature"],"version":"1","warnings":["Warnings Alcohol Warnings If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Do not use * with any other product containing acetaminophen * with any other product containing diphenhydramine, even one used on skin * in children under 12 years of age 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 pharmacists before use if you are taking sedatives or tranquilizers When using this product * do not exceed recommended dosage * avoid alcoholic beverages * marked drowsiness may occur * do not drive a motor vehicle or operate machinery Stop use and ask a doctor if * sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness * new symptoms occur * redness or swelling is present * pain gets worse or lasts more than 10 days * fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt 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 * do not exceed recommended dosage * avoid alcoholic beverages * marked drowsiness may occur * do not drive a motor vehicle or operate machinery"]}