FDA.reportPublic FDA data

NOTTS - Pain Relief PM

Manufacturer
VIVUNT PHARMA LLC
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:40:12

Label at a glance#

ProductNOTTS - Pain Relief PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporary relief of occasional headaches, 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 if needed, or as directed by a doctor. do not take more than 2 caplets in 24 hours children under 12 years do not use

Storage and handling

Store between 20-25°C (68-77°F) Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain Reliever
Diphenhydramine HCl 25 mgNighttime Sleep Aid

Uses

INDICATIONS & USAGE SECTION

Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • rash
  • blisters

If a skin reaction occurs, stop use and seek medical attention immediately.

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 are allergic to any other ingredient in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinatation due to enlargement of the prostate gland

When using this product

OTC - WHEN USING SECTION

avoid alcoholic drinks

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. 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 and children 12 years and over
  • take 2 caplets at bedtime if needed, or as directed by a doctor.
  • do not take more than 2 caplets in 24 hours
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • Store between 20-25°C (68-77°F)
  • Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Corn Starch, FD&C Blue No. 1 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Silicon Dioxide, Sodium Starch Glycolate, Talc, Titanium Dioxide.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol ® Extra Strength PM.

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida FL 33156-3178

Made in India

PRINCIPAL DISPLAY PANEL - 24 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

​500 mg/ 25 mg each caplet

Pain Reliever
Nighttime Sleep Aid
Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-01

24 CAPLETS

Pain Relief 24-01Pain Relief 24-01

PRINCIPAL DISPLAY PANEL - 50 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

500 mg/ 25 mg each caplet

​

  • Pain Reliever
  • Nighttime Sleep Aid
  • Non-habit Forming


Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-02

50 CAPLETS

Pain Relief 50-02Pain Relief 50-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN9
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD9
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY9

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
82706-009-012024-02-14C16284748780-11030e365-03e3-111a-e063-dadaa90a10e2NOTTS - Pain Relief PM
82706-009-022024-02-14C16284748780-11030e365-03e3-111a-e063-dadaa90a10e2NOTTS - Pain Relief PM
82706-009-012024-01-30C16284748780-11030e365-03e3-111a-e063-dadaa90a10e2NOTTS - Pain Relief PM
82706-009-022024-01-30C16284748780-11030e365-03e3-111a-e063-dadaa90a10e2NOTTS - Pain Relief PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-009-01NOTTS - Pain Relief PM24 in 1 BOTTLETABLET249
82706-009-01NOTTS - Pain Relief PM1 in 1 CARTONTABLET19
82706-009-02NOTTS - Pain Relief PM50 in 1 BOTTLETABLET509
82706-009-02NOTTS - Pain Relief PM1 in 1 CARTONTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-009NOTTS - PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VIVUNT PHARMA LLC]9Current NDC, Legacy NDC, 4 package rows20241204_e6754f62-e3b2-773f-e053-2a95a90ad36a.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-00982706-009-01, 82706-009-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STARCH, CORNO8232NY3SJIACT

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
NOTTS - Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLCe6754f62-e3b2-773f-e053-2a95a90ad36a2024-12-02WarningsExact identifier
ndc (package): 82706-009-01
ndc (package): 82706-009-02
ndc (product): 82706-009
ndc11 (package): 82706000901
ndc11 (package): 82706000902
spl id: 284f426f-6cb5-4e7e-e063-6294a90a946e
spl set id: e6754f62-e3b2-773f-e053-2a95a90ad36a

Reported adverse events (FAERS/openFDA)#

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