Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen
- Manufacturer
- FSA Store Inc.
- Effective date
- 2024-10-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:26:28
Label at a glance#
ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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
Storage and handling
store between 20-25°C (68-77°F) retain carton for complete product information
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- 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
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
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.
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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive ingredients
hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-844-705-4384
PRINCIPAL DISPLAY PANEL
caring mill™
NDC 81522-104-04
†Compare to the active ingredient in Tylenol® Extra Strength Caplets
Extra Strength
Acetaminophen
500 mg
Pain Reliever/Fever Reducer
For Adults
100 CAPLETS - 500 MG EACH
Actual Size
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81522-104-04 | AcetaminophenExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 4 | |
| 81522-104-04 | AcetaminophenExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 4 | |
| 81522-104-06 | AcetaminophenExtra Strength | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Extra Strength
- Acetaminophen
- HYPROMELLOSES
- MINERAL OIL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYSORBATE 80
- POVIDONE, UNSPECIFIED
- STARCH, PREGELATINIZED CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81522-104 | 81522-104-04, 81522-104-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen Extra Strength | ACETAMINOPHEN | FSA Store Inc. | ec6add55-f4a3-7818-e053-2a95a90aee04 | 2024-10-16 | Warnings | 81522-104-06 81522-104-04 81522-104 81522010406 81522010404 24996677-f6f7-01be-e063-6394a90a10d7 ec6add55-f4a3-7818-e053-2a95a90aee04 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.