Acetaminophen Diphenhydramine HCl

Manufacturer
BETTER LIVING BRANDS LLC.
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:27:21

Label at a glance#

ProductAcetaminophen Diphenhydramine HCl
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

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

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 ingredient

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 reaction. 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


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.

do not take more than directed (see overdose warning)

DOSAGE & ADMINISTRATION SECTION


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

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 Ingrdients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, 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 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20ct20ct

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80ct80ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY5

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
21130-354-02Acetaminophen Diphenhydramine HCl20 in 1 BOTTLETABLET205
21130-354-08Acetaminophen Diphenhydramine HCl80 in 1 BOTTLETABLET805

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-35421130-354-02, 21130-354-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
ndc (package): 21130-354-08
ndc (package): 21130-354-02
ndc (product): 21130-354
ndc11 (package): 21130035402
ndc11 (package): 21130035408
spl id: 463f0f6c-a15d-37d7-e063-6394a90a4c6c
spl set id: ac0f8d5c-d200-1156-e053-2a95a90aece6

Reported adverse events (FAERS/openFDA)#

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