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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0714-42 | 2025-02-07 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
| 0363-0714-42 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 24 in 1 BOTTLE | TABLET | 24 | 5 | |
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 1 in 1 CARTON | TABLET | 1 | 5 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength NiteTime Pain Relief
- Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet
- TITANIUM DIOXIDE
- STEARIC ACID
- FD&C BLUE NO. 1 ALUMINUM LAKE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE
- TALC
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ACETAMINOPHEN
- CARNAUBA WAX
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0714 | 0363-0714-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Extra Strength NiteTime Pain Relief | ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET | WALGREENS | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 2025-07-25 | Warnings | 0363-0714-42 0363-0714 00363071442 3ac05a52-7cce-2bfb-e063-6394a90a134b c25c75c7-157f-1c0d-e053-2995a90a2e3c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

