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
- PLD Acquisitions LLC DBA Avéma Pharma Solutions
- Effective date
- 2023-02-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:36:59
Label at a glance#
ProductPain Reliever 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 do not take for more than 10 days unless directed by a doctor children under 12 years: do not use
Storage and handling
store between 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
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 ever 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 a 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 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 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
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use
Other information
- store between 20-25°C (68-77°F)
Inactive ingredients
corn starch, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, povidone, stearic acid*, talc*, titanium dioxide
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the active ingredient in Tylenol® Extra Strength
Extra Strength
Pain Reliever
Acetaminophen, 500 mg
Pain Reliever/Fever Reducer
Caplets
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
Avema Pharma Solutions
10400 NW Terrace, Miami FL 33172
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63548-0494-1 | 2023-02-09 | C162847 | 48780-1 | f386c64a-482d-0266-e053-dadaa90a7c1a | Drug Facts |
| 63548-0494-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-482d-0266-e053-dadaa90a7c1a | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever Extra Strength
- Acetaminophen
- STARCH, CORN
- HYPROMELLOSES
- POVIDONE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- MALTODEXTRIN
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYDEXTROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63548-0494 | 63548-0494-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POLYDEXTROSE | VH2XOU12IE | 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 |
|---|---|---|---|---|---|---|
| d589a510-f44c-4dd1-a32a-e9cdf690a682 | 6b8d6cc9-abc4-4d82-a95d-9a6d3d5e390e | 2023-02-09 | Warnings | d589a510-f44c-4dd1-a32a-e9cdf690a682 6b8d6cc9-abc4-4d82-a95d-9a6d3d5e390e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.