{ "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": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "ZzzQuil Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN PROPYLENE GLYCOL WATER FD&C RED NO. 40 SORBITOL TITANIUM DIOXIDE Zzz" ], "spl_unclassified_section": [ "Drug Facts", "Made in Canada Dist. by Procter & Gamble, Cincinnati, OH 45202 Vicks® and LiquiCaps™ are trademarks of The Procter & Gamble Company used with permission. All other products and brands are the property of their respective owners. Product repackaged and distributed with permission of manufacturer by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 1-877-507-6516 M-F (8 AM-4:30 PM CST) 97461C-US-04-22" ], "active_ingredient": [ "Active ingredient (in each LiquiCap) Diphenhydramine hydrochloride 25 mg" ], "purpose": [ "Purpose Nighttime sleep-aid" ], "indications_and_usage": [ "Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep" ], "warnings": [ "Warnings Do not use 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 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 sedatives or tranquilizers When using this product avoid alcoholic beverages 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. 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." ], "do_not_use": [ "Do not use 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 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 sedatives or tranquilizers" ], "when_using": [ "When using this product avoid alcoholic beverages" ], "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." ], "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." ], "dosage_and_administration": [ "Directions take only one dose (2 LiquiCaps) per day (24 hours) adults & children 12 yrs & over 2 LiquiCaps at bedtime if needed or as directed by a doctor children under 12 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over2 LiquiCaps at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use
" ], "storage_and_handling": [ "Other information store at no greater than 25°C (77°F) avoid excessive heat above 40°C (104°F) protect from light." ], "inactive_ingredient": [ "Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, shellac*, sorbitan, sorbitol titanium dioxide*, water *May contain these ingredients" ], "questions": [ "Questions or comments? 1-877-881-5813" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 2 LiquiCap Blister Pack Carton Coupon Inside! Save $1.00 on your next purchase of ONE ZzzQuil® product (excludes trial/travel size). VICKS ® ZzzQuil ™ NIGHTTIME SLEEP-AID Diphenhydramine HCl Not for colds or pain Fall Asleep Fast Non-Habit Forming [LiquiCap image] 2 LiquiCaps™ [Lil' Drug Store ® logo] PDP/Package" ], "set_id": "0b2777be-85d4-443d-b65f-6750e0ba97ba", "id": "2733bf33-a0be-9d8a-e063-6294a90a26ad", "effective_time": "20241118", "version": "7", "openfda": { "application_number": [ "M010" ], "brand_name": [ "ZzzQuil" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-9746" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1049909", "1248360" ], "spl_id": [ "2733bf33-a0be-9d8a-e063-6294a90a26ad" ], "spl_set_id": [ "0b2777be-85d4-443d-b65f-6750e0ba97ba" ], "package_ndc": [ "66715-9746-1" ], "is_original_packager": [ true ], "unii": [ "TC2D6JAD40" ] } } ] }