Mediclarum
Medicine guide

Nighttime Sleep Aid

25 mg · Tablet

  • Available without prescription
  • Histamine-1 Receptor Antagonist
Made by
CHAIN DRUG MARKETING ASSOCIATION, 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 · 2024-08-12

What it is

Nighttime sleep-aid

Used for
  • Helps to reduce difficulty falling asleep
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
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
302other products contain Diphenhydramine Hydrochloride — compare makers, forms and strengths

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

What it is for

  • helps to reduce difficulty falling asleep

From the official label · 2024-08-12 · 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

  • in
  • 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.

  • adults and children 12 years of age and over:
  • take two tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years of age:
  • do not use

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

Ask a doctor first if

a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged 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 serious underlying medical illness.

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

Other warnings

  • Do not use in
  • 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 drowsiness will occur do not drive a motor vehicle or operate machinery
  • Stop use and
  • ask a doctor if sleeplessness persists continuously for more than 2 weeks.
  • Keep out of reach of children.
  • avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery

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 (1-800-222-1222).

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

How to store it

  • each tablet contains:
  • calcium 85 mg store between 20-25°C (68-77°F) retain carton for complete product information

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.

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

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

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

Canada23 matching products

Every strength and form (104)

Details

Made byCHAIN DRUG MARKETING ASSOCIATION, INC.
Active substanceDiphenhydramine Hydrochloride
Used inBreathing, airways, allergies and cough
Strength25 mg
FormTablet
RouteOral
Packs4 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK
NDC83324-110

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).

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Other strengths and forms

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

Show all forms · 7 forms

Same active substance

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

Adult Allergy Relief Dye Free25 mg/10mLWithout prescriptionSolution WALGREEN COMPANY · Diphenhydramine HydrochlorideAdwe Dye-Free Childrens Allergy12.5 mg/5mLWithout prescriptionSyrup RARITAN PHARMACEUTICALS INC · Diphenhydramine HydrochlorideAllergy25 mgWithout prescriptionTablet, Film Coated Kroger Company · Diphenhydramine HydrochlorideAllergy25 mgWithout prescriptionTablet, Film Coated Meijer Distribution Inc · Diphenhydramine HydrochlorideAllergy25 mgWithout prescriptionTablet, Coated Discount Drug Mart · Diphenhydramine HydrochlorideAllergy25 mgWithout prescriptionCapsule DISCOUNT DRUG MART · Diphenhydramine Hydrochloride

See every product with Diphenhydramine Hydrochloride