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
EXTRA STRENGTH PAIN RELEIF
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:39
Label at a glance#
ProductEXTRA STRENGTH PAIN RELEIF
Active ingredientACETAMINOPHEN
Label structure18 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)
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 SECTION
Warnings
SPL UNCLASSIFIED SECTION
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 | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
Inactive ingredients
Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Extra Strength
Pain Relief
Acetaminophen 500 mg - Pain Reliever / Fever Reducer
40 Caplets
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-4204-4 | 2026-01-29 | C162847 | 48780-1 | 49896155-a5b2-586f-e063-e6dba90add90 | EXTRA STRENGTH PAIN RELIEF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4204-4 | EXTRA STRENGTH PAIN RELEIF | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 68210-4204-4 | EXTRA STRENGTH PAIN RELEIF | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4204 | EXTRA STRENGTH PAIN RELEIF (ACETAMINOPHEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 5 | Legacy NDC, 2 package rows | 20241215_eda9e18e-418f-4640-a111-7c2cdd7a5703.zip |
Products#
Every source-derived product name is available through these pages.
- EXTRA STRENGTH PAIN RELEIF
- ACETAMINOPHEN
- HYPROMELLOSE 2208 (15000 MPA.S)
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4204 | 68210-4204-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSE 2208 (15000 MPA.S) | Z78RG6M2N2 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | 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 |
|---|---|---|---|---|---|---|
| 292dff2c-ae16-2b00-e063-6394a90a1aa5 | eda9e18e-418f-4640-a111-7c2cdd7a5703 | 2024-12-13 | Warnings | 292dff2c-ae16-2b00-e063-6394a90a1aa5 eda9e18e-418f-4640-a111-7c2cdd7a5703 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.