Extra Strength Pain Reliever
- Manufacturer
- WALGREENS | TIME CAP LABORATORIES, INC.
- Effective date
- 2025-01-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - STOP USE SECTION
Stop using and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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 (1-800-222-1222) right away. 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 tablets every 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
OTHER INFORMATION
Other information
store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized
starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient
OTC - QUESTIONS SECTION
Questions and comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0669-01 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-5a69-d83d-e063-dadaa90ab31f | 342R 0363 0669 Walgreens Acetaminophen 500 mg 100s |
| 0363-0669-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5a69-d83d-e063-dadaa90ab31f | 342R 0363 0669 Walgreens Acetaminophen 500 mg 100s |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0669-01 | Extra Strength Pain Reliever | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 0363-0669-01 | Extra Strength Pain Reliever | 1 in 1 CARTON | TABLET | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Extra Strength Pain Reliever
- Acetaminophen tablets 500 mg
- POVIDONE
- STEARIC ACID
- HYPROMELLOSE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- SUCRALOSE
- ACETAMINOPHEN
- CARNAUBA WAX
- FD&C RED NO. 40
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0669 | 0363-0669-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 Pain Reliever | ACETAMINOPHEN TABLETS 500 MG | WALGREENS | c25bfe92-0196-0489-e053-2995a90abea1 | 2025-01-30 | Warnings | 0363-0669-01 0363-0669 00363066901 2ce99cb7-fea1-5da2-e063-6294a90afc4e c25bfe92-0196-0489-e053-2995a90abea1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

