HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL

HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by HyVee Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 42507-834, application M010, label effective 20260821. It is one of 66 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIPHENHYDRAMINE HYDROCHLORIDE are most often described in connection with: relief occasional. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

​Uses • for relief of occasional sleeplessness

​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 ​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.

FDA lists 66 drug label records with DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL used for?
​Uses • for relief of occasional sleeplessness

Who makes HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL?
HyVee Inc is the labeler of record for HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL. 66 FDA label records share the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HYDROCHLORIDE?
Yes. 66 FDA drug label records list DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.