Indications and uses
temporarily relieves minor aches and pains due to: a cold headache arthritis muscular aches toothache premenstrual and menstrual cramps
temporarily relieves minor aches and pains due to: a cold headache arthritis muscular aches toothache premenstrual and menstrual cramps
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 do not take more than 8 caplets in 24 hours children under 12 years: ask a doctor
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
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:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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:
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.
if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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
1-800-426-9391
Fred's
Pharmacy
NDC 55315-934-15
Compare to the active ingredients in: Excedrin® Extra Strength Caplets†
EXTRA STRENGTH
HEADACHE RELIEF
Acetaminophen, Aspirin (NSAID), Caffeine
Pain Reliever/Pain Reliever Aid
50 CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Novartis AG, owner of the registered trademark Excedrin® Extra Strength Caplets.
50844 ORG011733415
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com
100% satisfaction
guaranteed

Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55315-934 | 55315-934-15 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|
| e5dc0d52-0cf6-4397-a1f3-9a1477265008 | ea54bc56-de2b-4bb2-b064-22c88cb3f1ae | 2020-06-11 | Warnings | e5dc0d52-0cf6-4397-a1f3-9a1477265008 ea54bc56-de2b-4bb2-b064-22c88cb3f1ae |
Adverse event summaries are temporarily unavailable. Other product information remains available.