Nighttime Sleep Aid Berry Flavor

DIPHENHYDRAMINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

Nighttime Sleep Aid Berry Flavor is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Raritan Pharmaceuticals 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 20260909.

Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Raritan Pharmaceuticals Inc
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
68163-730
Application
M012
Label effective
20260909

About this product

Nighttime Sleep Aid Berry Flavor is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by Raritan Pharmaceuticals Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-730, application M012, label effective 20260909. 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.

What it is used for

Across FDA labelling, products containing DIPHENHYDRAMINE HYDROCHLORIDE 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 the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

Directions ▪ take only one dose per day (24 hours) ▪ only use cup provided adults & children 12yrs & over One Dose 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs 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 two 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 at 1-800-222-1222.

More products with the same ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

ADWE dye-free childrens allergy

RARITAN PHARMACEUTICALS INC View label

Allergy

Velocity Pharma LLC View label

Allergy Childrens Allergy

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) View label

Allergy Relief

Amazon.com Services LLC View label

Allergy Relief

Health Pharma USA LLC View label

Allergy Relief

AMERIFOODS TRADING COMPANY View label

Benadryl

Proficient Rx LP View label

Benadryl

Kenvue Brands LLC View label

How products containing DIPHENHYDRAMINE HYDROCHLORIDE compare

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.

Dosage formProductsManufacturerProducts
— — CVS Pharmacy,Inc. 5
— — Advance Pharmaceutical Inc. 4
— — Cardinal Health 107, LLC 4
— — Medical Purchasing Solutions, LLC 4
— — Health Pharma USA LLC 3

Frequently asked questions

What is Nighttime Sleep Aid Berry Flavor used for?
Uses ▪ for the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep

Who makes Nighttime Sleep Aid Berry Flavor?
Raritan Pharmaceuticals Inc is the labeler of record for Nighttime Sleep Aid Berry Flavor. 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 Nighttime Sleep Aid Berry Flavor 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 Berry Flavor 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 Nighttime Sleep Aid Berry Flavor 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.