Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ he common cold ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ he common cold ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ do not take more than directed (see overdose warning) 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 more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date
(in each Gelcap)
Acetaminophen, USP 500 mg
Pain reliever/fever reducer
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ toothache
■ he common cold
■ premenstrual and menstrual cramps
■ temporarily reduces fever
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
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.
■ 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 have ever had an allergic reaction to this product or any of its ingredients
liver disease.
taking the blood thinning drug warfarin.
■ 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.
ask a health professional before use.
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.
In case of accidental overdose, get medical help or contact a Poison Control Centerright 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.
■ do not take more than directed (see overdose warning)
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 more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for lot number and expiration date
ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69848-008-10 | 2020-12-30 | C162847 | 48780-1 | ab0e2407-2992-f274-e053-dbdaa90a6471 | EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free |
| 69848-008-10 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2992-f274-e053-dbdaa90a6471 | EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free |
| 69848-008-10 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2992-f274-e053-dbdaa90a6471 | EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free |
| 69848-008-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2992-f274-e053-dbdaa90a6471 | EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69848-008-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69848-008 | 69848-008-10 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc | a51395ea-e038-dc9c-e053-2a95a90a287d | 2025-12-22 | Warnings | 69848-008-10 69848-008 69848000810 468e7582-908f-6ec4-e063-6394a90a1653 a51395ea-e038-dc9c-e053-2a95a90a287d |
Adverse event summaries are temporarily unavailable. Other product information remains available.