Nighttime Sleep Aid Alcohol Free

DIPHENHYDRAMINE HCL ORAL HUMAN OTC DRUG

Nighttime Sleep Aid Alcohol Free is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCL manufactured by Wal-Mart Stores Inc administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260805.

Generic name
DIPHENHYDRAMINE HCL
Manufacturer
Wal-Mart Stores Inc
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
49035-330
Application
M010
Label effective
20260805

About this product

Nighttime Sleep Aid Alcohol Free is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HCL. It is labelled by Wal-Mart Stores Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49035-330, application M010, label effective 20260805. 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.

What it is used for

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.

Active ingredients

Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed mL = milliliter only use the dose cup provided take only one dose per day (24 hours) adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor children under 12 years: do not use

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.

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How products containing DIPHENHYDRAMINE HCL compare

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.

Dosage formProductsManufacturerProducts
— — Walgreen Company 7
— — Rite Aid Corporation 6
— — CalmCo LLC 5
— — DOLGENCORP, LLC 5
— — Wal-Mart Stores Inc 5

Frequently asked questions

What is Nighttime Sleep Aid Alcohol Free used for?
Uses for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Who makes Nighttime Sleep Aid Alcohol Free?
Wal-Mart Stores Inc is the labeler of record for Nighttime Sleep Aid Alcohol Free. 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 Nighttime Sleep Aid Alcohol Free 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 Nighttime Sleep Aid Alcohol Free 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 Nighttime Sleep Aid Alcohol Free 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.