Extra Strength NiteTime Pain Relief

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-07-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:09:42

Label at a glance#

ProductExtra Strength NiteTime Pain Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever
Nighttime sleep aid

INDICATIONS & USAGE SECTION

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

WARNINGS SECTION

Warnings
Liver warning: 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

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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: 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

SPL UNCLASSIFIED SECTION

Other information

  • store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide
**may contain this ingredient

OTC - QUESTIONS SECTION

Questions or comments? call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

430R_WALG_24CT_IFC430R_WALG_24CT_IFC

430R_WALG_24CT_LBL430R_WALG_24CT_LBL

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0714-42Extra Strength NiteTime Pain Relief24 in 1 BOTTLETABLET245
0363-0714-42Extra Strength NiteTime Pain Relief1 in 1 CARTONTABLET15

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-07140363-0714-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
ndc (package): 0363-0714-42
ndc (product): 0363-0714
ndc11 (package): 00363071442
spl id: 3ac05a52-7cce-2bfb-e063-6394a90a134b
spl set id: c25c75c7-157f-1c0d-e053-2995a90a2e3c

Reported adverse events (FAERS/openFDA)#

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