Sleep Tabs

Sleep Tabs is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HCL. It is labelled by Major Pharmaceuticals taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0904-4274, application M010, label effective 20260803. It is one of 90 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HCL. 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 HCL are most often described in connection with: relief occasional, sleeplessness reduces, time fall, difficulty falling. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use s for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Directions do not take more than directed adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use

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 glaucoma a breathing problem such as emphysema or chronic bronchitis 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 a 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.

FDA lists 90 drug label records with DIPHENHYDRAMINE HCL 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sleep Tabs used for?
Use s for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Who makes Sleep Tabs?
Major Pharmaceuticals is the labeler of record for Sleep Tabs. 90 FDA label records share the active ingredient DIPHENHYDRAMINE HCL, 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 Sleep Tabs 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 Sleep Tabs 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 HCL?
Yes. 90 FDA drug label records list DIPHENHYDRAMINE HCL 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 Sleep Tabs been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.