Acetaminophen Diphenhydramine HCl

Manufacturer
Granules USA, Inc.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:27:56

Label at a glance#

ProductAcetaminophen Diphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, 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 andchildren 12 years and over ■ take 2 caplets at bedtime do not use ■ 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 expiration date and lot number

Label contents#

Full prescribing information#

Active ingridients

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Acetaminophen, USP 500mg

Diphenhydramine HCl. 25mg

Purposes

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 containsacetaminophen. 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 severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away

DSo 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 brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma

Ask a doctor or pharmacist before use if you have

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 morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 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 (1-800-222-1222) right away. Prompt 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 andchildren 12 years and over

■ take 2 caplets at bedtime do not use
■ 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 expiration date and lot number

Inactive ingridients

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, povidone,pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20ct20ct

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ct50ct

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150ct150ct

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69848-014-022020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-014-02Acetaminophen Diphenhydramine HCl20 in 1 BOTTLETABLET207
69848-014-05Acetaminophen Diphenhydramine HCl50 in 1 BOTTLETABLET507
69848-014-15Acetaminophen Diphenhydramine HCl150 in 1 BOTTLETABLET1507

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69848-01469848-014-02, 69848-014-05, 69848-014-15

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 Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
ndc (package): 69848-014-05
ndc (package): 69848-014-02
ndc (package): 69848-014-15
ndc (product): 69848-014
ndc11 (package): 69848001402
ndc11 (package): 69848001405
ndc11 (package): 69848001415
spl id: 4690f59f-4424-6231-e063-6294a90a8ca7
spl set id: 8c9f68e3-fedc-6457-e053-2995a90a045a

Reported adverse events (FAERS/openFDA)#

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