FDA.reportPublic FDA data

Acetaminophen, Diphenhydramine Hydrochloride

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:47:54

Label at a glance#

ProductAcetaminophen, Diphenhydramine Hydrochloride
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years of age 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • drowsiness will occur

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 of age 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

Other information

OTHER SAFETY INFORMATION

  • store in a dry place at 15°-30°C (59°-86°F).
  • see end flap for expiration date and lot number.

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

© 2025 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

100% Money Back Guarantee

Return to place of purchase if not satisfied

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0411-3

Extra Strength Acetaminophen PM

Acetaminophen, 500 mg

Diphenhydramine HCl, 25 mg

Pain Reliever/Nighttime Sleep-Aid

COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients*

100 CAPLETS

Leader labelLeader label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN7
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD7
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride24 in 1 BOTTLETABLET, FILM COATED247
70000-0411-2Acetaminophen, Diphenhydramine Hydrochloride50 in 1 BOTTLETABLET, FILM COATED507
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0411-1EA - Each70000-041115fd30a1-2ad7-436f-be92-9b92e7c98b6712019-08-06
70000-0411-2EA - Each70000-041138d72d75-ca00-495d-ba2f-f47c8f99fd2112019-08-06
70000-0411-3EA - Each70000-041188c57048-0046-45d5-8256-8d2dfb5493ff12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-041170000-0411-2, 70000-0411-1, 70000-0411-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STEARIC ACID4ELV7Z65APIACT
LIGHT MINERAL OILN6K5787QVPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
TRIACETINXHX3C3X673IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
HYPROMELLOSES3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.7be4d67e-1af9-f059-e053-2991aa0a382e2026-02-26WarningsExact identifier
ndc (package): 70000-0411-1
ndc (package): 70000-0411-3
ndc (package): 70000-0411-2
ndc (product): 70000-0411
ndc11 (package): 70000041102
ndc11 (package): 70000041103
ndc11 (package): 70000041101
spl id: 4bbe57b4-c0c6-c37f-e063-6294a90a7dd7
spl set id: 7be4d67e-1af9-f059-e053-2991aa0a382e

Reported adverse events (FAERS/openFDA)#

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