Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDIPHENHYDRAMINE HYDROCHLORIDE
Labeler / manufacturerHyVee Inc
RouteORAL
Drug classDrug class not supplied in source label
Product NDC42507-834
Label effective date2026-08-21
Official product label reference
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL — HyVee Inc
This page contains 10 source sections for DIPHENHYDRAMINE HYDROCHLORIDE, oral route. Label set 496ce4ba-08a9-ee99-e063-6294a90ac9a7, version 2.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses • for relief of occasional sleeplessness
Purpose
Purpose Nighttime sleep-aid
Dosage and administration — label text
Directions • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
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 • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Unclassified section
Drug Facts
*Compare to the Active Ingredient of Unisom ® SleepGels ® Helps Fall Asleep Fast READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY HY-VEE, INC. WEST DES MOINES, IA 50266 STVA0126 PRODUCT OF INDIA SATISFACTION GUARANTEED CALL 1-800-289-8343 www.hy-vee.com TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom®.
Active ingredient
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
Child safety
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Other information • store at 20-25°C (68-77° F) • keep bottle tightly closed • protect from light, heat and moisture
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.