CAREALL Pain Relief PM

Manufacturer
New World Imports, Inc
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:00

Label at a glance#

ProductCAREALL Pain Relief PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves 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 older: Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours Children under 12 years: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nightime sleep aid

Keep Out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental overdose, contact a doctor or 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.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves 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
• More than 4000 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.

Do not use:

  • 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 even had an allergic reaction to this product or any of its ingredients

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

Ask a doctor or pharmacist before use if you are:

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

When using this product:

•drowsiness will occur

•do not drive a motor vehicle or operate machinery

•avoid alcoholic drinks

Stop use and ask a doctor if:

•sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

•pain gets worse or last for more than 10 days.

•fever gets worse or last for more than 3 days

•redness or swelling are present

•new symptoms occur.  These could be signs of a serious condition.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed.  (see overdose warning)

Adults and children 12 years of age and older:Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours

Children under 12 years:do not use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD and C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.  

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085317004903GTIN-13: 0085317004903
EAN-13: 0085317004903
GTIN-12: 085317004903
UPC-A: 085317004903
GTIN storage (14 digits): 00085317004903
PMC50024 107-50.jpg

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
51824-107-50CAREALL Pain Relief PMExtra Strength50 in 1 BOTTLETABLET502

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
51824-10751824-107-50

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
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
ndc (package): 51824-107-50
ndc (product): 51824-107
ndc11 (package): 51824010750
spl id: 46905264-466d-6fd8-e063-6394a90ae817
spl set id: c93aa5e4-3994-439f-8f14-4e81773ed4e2

Reported adverse events (FAERS/openFDA)#

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