Acetaminophen Diphenhydramine HCl

Manufacturer
CVS Pharmacy, Inc.
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:34:35

Label at a glance#

ProductAcetaminophen Diphenhydramine HCl
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

temporary relief of occasional headaches and minor aches and pains with accaompanying sleeplessness.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl, USP 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

temporary relief of occasional headaches and minor aches and pains with accaompanying sleeplessness.

Liver warning

WARNINGS SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see overdose warning)

adults and children 12 years and over

■ take 2 gelcaps at bedtime

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

children under 12 years: do not use

Other information

OTHER SAFETY INFORMATION

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ see bottom of the panel for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 count250 count20 count20 count80 count80 count

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-306-022023-03-15C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082023-03-15C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252023-03-15C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-022023-01-30C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082023-01-30C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252023-01-30C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-022020-12-29C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082020-12-29C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252020-12-29C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-022020-09-27C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082020-09-27C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252020-09-27C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-022020-09-25C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082020-09-25C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252020-09-25C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-022020-07-22C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-082020-07-22C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg
69842-306-252020-07-22C16284748780-1ab0e2407-2cac-f274-e053-dbdaa90a6471EXTRA STRENGTH Acetaminophen PM ACETAMINOPHEN, USP 500 mg DIPHENHYDRAMINE HCl, USP 25 mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-30669842-306-02, 69842-306-08, 69842-306-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10434aa8-7153-5a87-e063-6294a90a6ffb6b6787da-0c29-42fb-e053-2991aa0a6c522024-01-31WarningsExact identifier
spl set id: 6b6787da-0c29-42fb-e053-2991aa0a6c52

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.