Indications and uses
temporarily relieves minor aches and pains due to: muscular aches headache backache the common cold toothache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Harmon Store Inc. | LNK International, Inc.
- Effective date
- 2022-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:43:51
Label at a glance#
ProductPain Reliever Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.facevalues.com
www.facevalues.com
www.facevalues.comLabel contents#
Full prescribing information#
Active ingredient (in each gelcap)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- muscular aches
- headache
- backache
- the common cold
- toothache
- minor pain of arthritis
- 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:
- rash
- skin reddening
- blisters
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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 directed
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
CORE VALUES™
Compare to active ingredient in
Extra Strength Tylenol® Rapid Release†
Extra Strength
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin • Rapid Release
Actual Size
24 Gelcaps
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Extra Strength Tylenol®
Rapid Release.
50844 ORG041751908
Distributed by: Liberty Procurement Co. Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com
Products#
Every source-derived product name is available through these pages.
- Pain Reliever Extra Strength
- Acetaminophen
- CROSCARMELLOSE SODIUM
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN
- HYPROMELLOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- SHELLAC
- STEARIC ACID
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63940-519 | 63940-519-08, 63940-519-29, 63940-519-19 |
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 |
|---|---|---|---|---|---|---|
| a0f927c2-d609-438c-8a97-11628c1c3b6a | b0a70a8a-d9f2-481b-82b5-0a5f64869a0d | 2023-04-28 | Warnings | b0a70a8a-d9f2-481b-82b5-0a5f64869a0d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.