{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 500mg Diphenhydramine HCl 25mg"],"dosage_and_administration":["Directions: • take with a full glass of water • Do not take more than directed. SEE OVERDOSE WARNING. • do not take more than 2 caplets in 24 hours adults and children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years of age • do not use"],"dosage_and_administration_table":["
adults and children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours
children under 12 years of age • do not use
"],"effective_time":"20201119","id":"ec528ea0-2522-4f3b-87dd-0fd9efa639f2","inactive_ingredient":["Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide."],"indications_and_usage":["Uses: • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children. OVERDOSE WARNINGS: 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":["Packaging IMAGE"],"purpose":["Purpose Pain reliever Nighttime sleep aid"],"questions":["Questions or comments? 1-833-665-9444. (Mon-Fri 9am-5pm)"],"set_id":"ff61406a-ca7c-4b8d-a730-8bdbceab0389","spl_product_data_elements":["Only For BODY PAIN Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE LIGHT BLUE AD01"],"spl_unclassified_section":["Drug Facts","ADULT PAIN RELIEVER NIGHTTIME SLEEP AID TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing Distributed By: O4 GLOBAL TRADING USA, LLC. 12222 Merit Drive, Suite 1900 Dallas, TX 75251-3209 www.onlyfor.com Packaged By: Strive Pharmaceuticals Inc. East Brunswick, NJ 08816."],"storage_and_handling":["Other Information: • Store at room temperature between 20-25°C (68-77°F). • avoid excessive heat, cold and humidity. • close cap tightly after use."],"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 every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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 • 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 last more than 3 days • redness or swelling is present • new symptoms occur. 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 WARNINGS: 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."]}