Acetaminophen and Diphenhydramine HCL

Manufacturer
PUBLIX SUPERMARKETS, INC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:27:04

Label at a glance#

ProductAcetaminophen and Diphenhydramine HCL
Active ingredientDIPHENHYDRAMINE, ACETAMINOPHEN
Label structure18 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 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

Storage and handling

■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature. ■ see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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 accompanying 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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose warning:

OVERDOSAGE SECTION

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 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

STORAGE AND HANDLING SECTION

■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
■ see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ct50ct100ct100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN6
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD6
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-661-05Acetaminophen and Diphenhydramine HCL50 in 1 BOTTLETABLET506
41415-661-10Acetaminophen and Diphenhydramine HCL100 in 1 BOTTLETABLET1006

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41415-66141415-661-05, 41415-661-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLPUBLIX SUPERMARKETS, INC08f549cf-042a-7bf2-e063-6394a90a83ef2025-12-19WarningsExact identifier
ndc (package): 41415-661-05
ndc (package): 41415-661-10
ndc (product): 41415-661
ndc11 (package): 41415066110
ndc11 (package): 41415066105
spl id: 465302f5-b590-5105-e063-6394a90aa9d0
spl set id: 08f549cf-042a-7bf2-e063-6394a90a83ef

Reported adverse events (FAERS/openFDA)#

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