Acetaminophen and Diphenhydramine hydrochloride

Manufacturer
KROGER COMPANY | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2024-09-10
Label type
Human OTC Drug Label
Version
5
Source
full-release
Hydrated at
2026-06-01 00:20:08

Label at a glance#

ProductAcetaminophen and Diphenhydramine hydrochloride
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 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 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

Storage and handling

avoid high humidity store at 20º to 25°C (68º to 77°F) use by expiration date on package

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride 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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the 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 beverages
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

In case of accidental 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
  • 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

  • avoid high humidity
  • store at 20º to 25°C (68º to 77°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-193-14
Kroger®
               
health

NON-HABIT
FORMING

EXTRA STRENGTH

Acetaminophen
PM
Acetaminophen USP, 500 mg

Diphenhydramine
Hydrochloride USP, 25 mg

PAIN RELIEVER,
NIGHTTIME SLEEP-AID
RAPID RELEASE

50
GELCAPS



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-193-14

Kroger®
              
health

COMPARE TO THE ACTIVE INGREDIENTS
OF EXTRA STRENGTH TYLENOL® PM*

NON-HABIT
FORMING

EXTRA STRENGTH

Acetaminophen PM
Acetaminophen USP, 500 mg
Diphenhydramine Hydrochloride USP, 25 mg

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

PAIN RELIEVER,
NIGHTTIME SLEEP-AID
RAPID RELEASE

50 GELCAPS               
 ACTUAL SIZE



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)

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
30142-193-14Acetaminophen and Diphenhydramine hydrochloride1 in 1 CARTONTABLET15
30142-193-14Acetaminophen and Diphenhydramine hydrochloride50 in 1 BOTTLETABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-193ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20240926_b9b86755-63ad-e25a-e053-2995a90ad747.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-19330142-193-14

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
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsExact identifier
ndc (package): 30142-193-14
ndc (product): 30142-193
ndc11 (package): 30142019314
spl id: 539e230b-aef0-4660-915d-b03b90d647d0
spl set id: b9b86755-63ad-e25a-e053-2995a90ad747

Reported adverse events (FAERS/openFDA)#

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