Medicine guide

Sleep

25 mg · Tablet

  • Available without prescription
  • Histamine-1 Receptor Antagonist
Active substance
Diphenhydramine Hcl
Made by
Salado Sales, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-11-24

What it is

Nighttime sleep-aid

Used for
  • For relief of occasional sleeplessness reduces time to fall asleep
  • If you have difficulty falling asleep
How to take it

Adults and children 12 years and over:: take 2 tablets at bedtime if needed or as directed by a doctor

Full directions ↓
Do not take it if

Children under 12 years of age with any other product containing diphenhydramine, even one used on skin

All warnings ↓
Good to know
  • Sold without a prescription
  • Mediclarum could not reach the FDA to check for recalls just now. This is not a result.
302other products contain Diphenhydramine Hcl — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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

From the official label · 2025-11-24 · DailyMed

How it works

From the US prescribing label for the same active substance (Diphenhydramine HCL). It describes the substance, not this exact product.

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects.

Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

How it leaves the body

Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-03

Do not take it if

  • for
  • children under 12 years of age with any other product containing diphenhydramine, even one used on skin

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are taking sedatives or tranquilizers.

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

  • Do not use for
  • 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.
  • Keep out of reach of children.
  • avoid alcoholic beverages.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from children

In case of overdose, get medical help or contact a Poison Control Center right away.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

How to store it

  • each tablet contains:
  • calcium 60 mg TAMPER EVIDENT:
  • DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Nighttime sleep-aid

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-800-426-9391

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Colour dyesFD&C blue #1 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (186)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 80 of 80 (the first 80 are listed)

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Made bySalado Sales, Inc.
Active substanceDiphenhydramine Hcl
Used inBreathing, airways, allergies and cough
Strength25 mg
FormTablet
RouteOral
Packs2 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK
NDC57243-189

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.