{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "CVS Nighttime Sleep Aid Diphenhydramine Hydrochloride and Acetaminophen CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 mg" ], "purpose": [ "Purpose Pain reliever Nighttime sleep-aid" ], "indications_and_usage": [ "Uses for the temporary relief of occasional minor aches and pains with accompanying sleeplessness." ], "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." ], "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." ], "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" ], "when_using": [ "When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery" ], "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "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." ], "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": [ "
adults & children 12 yrs & over30 mL at bedtime
children under 12 yrsdo not use
" ], "storage_and_handling": [ "Other information each 30 mL contains: sodium 10 mg store at room temperature very low sodium" ], "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." ], "questions": [ "Questions or comments? 1-866-467-2748" ], "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" ], "set_id": "333e170e-52cd-4218-8d15-0bf3c5c75cb9", "id": "456f7bf8-ad25-0cef-e063-6394a90a66e7", "effective_time": "20251208", "version": "6", "openfda": { "application_number": [ "M010" ], "brand_name": [ "CVS Nighttime Sleep Aid" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN" ], "manufacturer_name": [ "CVS PHARMACY" ], "product_ndc": [ "69842-448" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1092373" ], "spl_id": [ "456f7bf8-ad25-0cef-e063-6394a90a66e7" ], "spl_set_id": [ "333e170e-52cd-4218-8d15-0bf3c5c75cb9" ], "package_ndc": [ "69842-448-12" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "TC2D6JAD40" ] } } ] }