Indications and uses
temporarily relieves minor aches and pains
temporarily relieves minor aches and pains
do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12: ask a doctor
ACETAMINOPHEN 250 MG
ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)
CAFFEINE 65 MG
PAIN RELIEVER - PAIN RELIEVER AID
Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or
flu-like symptoms should not use this product. When using this product, if changes in
behavior with nausea and vomiting occur, consult a doctor because these symptoms could
be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
• hives • facial swelling • asthma (wheezing) • shock
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.
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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach
bleeding. The chance is higher if you • have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription
or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • are age 60 or older
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Caffeine warning: The recommended dose of this product contains about as much
caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or
beverages while taking this product because too much caffeine may cause nervousness,
irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professionalbefore use. It is especially
important not to use aspirin at 20 weeks or later in pregnancy unless definitely
directed to do so by a doctor because it may cause problems in the unborn child or
complications during delivery.
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.
corn starch, crospovidone, hypromellose,
microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate,
sodium starch glycolate, stearic acid, titanium dioxide
1-800-540-3765
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57896-216-01 | 2022-11-17 | C162847 | 48780-1 | d6a99b39-4c3c-a426-e053-dadaa90af4c2 | GC 226L (216) |
| 57896-216-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4c3c-a426-e053-dadaa90af4c2 | GC 226L (216) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-216-01 | EXTRA STRENGTH PAIN RELIEVER | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57896-216 | 57896-216-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH PAIN RELIEVER | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Geri-Care Pharmaceutical Corp | b670a898-2360-76e2-e053-2a95a90a3380 | 2025-11-17 | Warnings | 57896-216-01 57896-216 57896021601 43cfdcf7-0ae9-3cf5-e063-6294a90a5e7b b670a898-2360-76e2-e053-2a95a90a3380 |
Adverse event summaries are temporarily unavailable. Other product information remains available.