Indications and uses
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
Directions do not use more than directed drink a full glass of water with each dose adults and children (12 years and over) 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours children under 12 years ask a doctor
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
temporarily relieves minor aches and pains due to:
Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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 taking
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
| adults and children (12 years and over) | 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours |
| children under 12 years | ask a doctor |
Other information
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc
Questions or comments?
call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
Extra Strength
Headache Relief
Acetaminophen 250 mg Pain Reliever
Aspirin (NSAID*) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid
[caplets image]
ACTUAL SIZE
50 CPLETS
25 POUCHES 2 CAPLETS PER POUCH
[Lil' Drug Store ® logo]
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-6438-6 | Extra Strength Headache, Lil Drug Store | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 66715-6438-6 | Extra Strength Headache, Lil Drug Store | 25 in 1 BOX, UNIT-DOSE | TABLET | 25 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-6438 | EXTRA STRENGTH HEADACHE, LIL DRUG STORE (EXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.] | 2 | Current NDC, 2 package rows | 20250101_0c41deda-490b-f5d2-e063-6394a90a5047.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66715-6438 | 66715-6438-6 |
| 68210-0107 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TALC | 7SEV7J4R1U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 Headache, Lil Drug Store | EXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0c41deda-490b-f5d2-e063-6394a90a5047 | 2024-12-31 | Warnings | 66715-6438-6 66715-6438 66715643806 2a91cd0b-dcbf-25d2-e063-6294a90a6778 0c41deda-490b-f5d2-e063-6394a90a5047 |
Adverse event summaries are temporarily unavailable. Other product information remains available.