Medicine guide

Tylenol Pm Extra Strength, Cvp Health

25 mg + 500 mg · Tablet, Film Coated

Available without prescription
Histamine-1 Receptor Antagonist

Active substance: Acetaminophen and Diphenhydramine Hydrochloride
Used in: Breathing, airways, allergies and cough
Made by: Lil' Drug Store Products, Inc.
Source: Official label

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 · 2025-12-10

What it is

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid

Used for

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

How to take it

Adults and children 12 years and over: take 2 caplets at bedtime

do not take more than 2 caplets of this product in 24 hours

Full directions ↓

Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

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

35other products contain Acetaminophen and 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

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

From the official label · 2025-12-10 · DailyMed

Do not take it if

with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen,
ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in
children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

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 (see overdose warning )
adults and children 12 years and over
take 2 caplets at bedtime
do not take more than 2 caplets of this product in 24 hours
children under 12 years
do not use

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

Ask a doctor first if

liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma

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

Ask a pharmacist first if

you are taking the blood thinning drug warfarin 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. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

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

Other warnings

Liver warning This product contains acetaminophen.
Severe liver damage may occur
if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert:
acetaminophen may cause severe skin reactions.
Symptoms may include:
skin reddening blisters rash If a skin reaction occurs,
stop use and seek medical help right away.
Do not use with any other drug containing acetaminophen (prescription or nonprescription).
Ask a doctor before use
if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma
Ask a doctor or pharmacist before use
if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
When using this product drowsiness will occur
avoid alcoholic drinks 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.
Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222) Quick medical attention is critical for
adults as well as for children even
if you do not notice any signs or symptoms.
drowsiness will occur
avoid alcoholic drinks 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”.

How to store it

store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

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

What kind of medicine it is

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg 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.

carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

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

Questions about this product

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

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 no. 1 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

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 (11)

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

Showing 11 of 11

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

Canada1 matching products

ACETAMINOPHEN WITH ANTIHISTAMINE NIGHTTIME 25 mg + 500 mg · tabletWithout prescription

Every strength and form (4)

Details

Made by	Lil' Drug Store Products, Inc.
Active substance	Acetaminophen and Diphenhydramine Hydrochloride
Used in	Breathing, airways, allergies and cough
Strength	25 mg + 500 mg
Form	Tablet, Film Coated
Route	Oral
Packs	2 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH · 25 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH
NDC	66715-6417

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

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

Tablet, Film Coated2 products
- 25 mg + 500 mg
- 500 mg + 25 mg

Same active substance

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

See every product with Acetaminophen and Diphenhydramine Hydrochloride