Indications and 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
pain reliever
- Manufacturer
- Walgreens
- Effective date
- 2020-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:07:38
Label at a glance#
Productpain reliever extra strength
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than 6 capsules in any 24-hour period do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 capsules every 6 hours while symptoms last do not take more than 10 days unless directed by a doctor children under 12 years: do not use
Storage and handling
each capsule contains: sodium 9 mg do not chew, crush, or dissolve capsule before swallowing store between 15-30ºC (59-86ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each capsule)
Acetaminophen 500 mg
Purpose
Pain reliever/ fever reducer
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
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.
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
Ask a doctor before use if you have
liver disease
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Stop use 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.
If pregnant or breast-feeding,
ask a health professional before use.
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.
Directions
- do not take more than 6 capsules in any 24-hour period
- do not take more than directed (see Overdose warning)
- adults and children 12 years and over
- take 2 capsules every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
Other information
- each capsule contains: sodium 9 mg
- do not chew, crush, or dissolve capsule before swallowing
- store between 15-30ºC (59-86ºF)
Inactive ingredients
FD&C red #40, gelatin, glycerin, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, purified water,sodium hydroxide, sorbitan, sorbitol, titanium dioxide
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg / Pain Reliever / Fever Reducer
SOFTGELS*
(*Liquid-Filled Capsules)
Compare to Tylenol® Extra Strength active ingredient≠≠
≠≠This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: WALGREENS CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0711-01 | EA - Each | 0363-0711 | f0cf2918-3c11-452f-ac41-437f2eab9927 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- pain reliever extra strength
- Acetaminophen
- GELATIN
- GLYCERIN
- POVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- TITANIUM DIOXIDE
- FD&C RED NO. 40
- POTASSIUM HYDROXIDE
- SODIUM HYDROXIDE
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0711 | 0363-0711-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POVIDONE | FZ989GH94E | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBITAN | 6O92ICV9RU | 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 |
|---|---|---|---|---|---|---|
| 16c8f847-c66b-49f8-93ce-5b4a805e87b9 | ef6a6dfd-9705-4caf-b5ca-5d303bda2fa4 | 2020-11-11 | Warnings | 16c8f847-c66b-49f8-93ce-5b4a805e87b9 ef6a6dfd-9705-4caf-b5ca-5d303bda2fa4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.