FDA.reportPublic FDA data

EXTRA STRENGTH NO-PAIN PM

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2021-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:37

Label at a glance#

ProductEXTRA STRENGTH NO-PAIN PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 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 and children 12 years and over:  take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years:   do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Storage and handling

store between 20-25°C (68-77°F) do not use if pouch is torn or open see side panel for lot number and expiration date

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 and 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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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

Taking more than the recommended dose (overdose) may cause liver damage. 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.

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
  • do not take more than 2 caplets of this product in 24 hours
  • children under 12 years:  do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake,
magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol,
povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Compare to the Active Ingredients in
Tylenol PM ®*

Pain Relief PM

★Pain Reliever ★Nighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

apap pmapap pm

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
71309-006-022023-01-30C16284748780-1f386c649-b234-0266-e053-dadaa90a7c1aPain Relief PM - Acetaminophen and Diphenhydramine HCl
71309-006-252023-01-30C16284748780-1f386c649-b234-0266-e053-dadaa90a7c1aPain Relief PM - Acetaminophen and Diphenhydramine HCl
71309-006-372023-01-30C16284748780-1f386c649-b234-0266-e053-dadaa90a7c1aPain Relief PM - Acetaminophen and Diphenhydramine HCl
71309-006-502023-01-30C16284748780-1f386c649-b234-0266-e053-dadaa90a7c1aPain Relief PM - Acetaminophen and Diphenhydramine HCl

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
71309-00671309-006-25, 71309-006-50, 71309-006-02, 71309-006-30, 71309-006-05, 71309-006-37

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. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML · Source PDF

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
c3a3d290-045b-324c-e053-2995a90a3a3887655c3e-acab-bdc2-e053-2a95a90ae2a12021-05-31WarningsExact identifier
spl id: c3a3d290-045b-324c-e053-2995a90a3a38
spl set id: 87655c3e-acab-bdc2-e053-2a95a90ae2a1

Reported adverse events (FAERS/openFDA)#

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