{"active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • 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 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. ▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin."],"dosage_and_administration":["Directions ▪ take only one dose (30 mL) per day (24 hours) ▪ Only use dose cup provided adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use"],"dosage_and_administration_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults &amp; children 12 yrs &amp; over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>30 mL at bedtime</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>children under 12 yrs</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260814","id":"335bccb9-9abe-4e6f-b081-ff5cc3b464ba","inactive_ingredient":["Inactive ingredients citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose."],"indications_and_usage":["Uses ▪ for the temporary relief of occasional minor aches and pains with accompanying sleeplessness."],"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 right away at 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."],"openfda":{"application_number":["M010"],"brand_name":["CVS Nighttime Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY"],"package_ndc":["69842-448-12"],"product_ndc":["69842-448"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092373"],"spl_id":["335bccb9-9abe-4e6f-b081-ff5cc3b464ba"],"spl_set_id":["333e170e-52cd-4218-8d15-0bf3c5c75cb9"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 354 ml bottle Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid* NDC# 69842-448-12 Nighttime Sleep-Aid Pain Reliever Diphenhydramine HCl Acetaminophen • Fall Asleep Fast • Max Strength Pain Reliever • Non-Habit Forming Berry Flavor Naturally and Artificially Flavored No Added Alcohol 12 FL. OZ. (354 ml) *This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nigh Pain Sleep-Aid. Distributed by: CVS Nighttime Sleep Aid Berry Flavor"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep-aid"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"333e170e-52cd-4218-8d15-0bf3c5c75cb9","spl_product_data_elements":["CVS Nighttime Sleep Aid Diphenhydramine Hydrochloride and Acetaminophen ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. These could be signs of a serious condition."],"storage_and_handling":["Other information ▪ each 30 mL contains: sodium 10 mg ▪ store at room temperature ▪ very low sodium"],"version":"7","warnings":["Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if ▪ adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product ▪ taken 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. ▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have • liver disease • 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 the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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. In case of overdose, get medical help or contact a Poison Control Center right away at 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 • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery"]}