Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
Extraprin
- Manufacturer
- Magno-Humphries, Inc.
- Effective date
- 2023-10-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:14
Label at a glance#
ProductExtraprin
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 sections
Dosage and administration
do not use more than directed drink a full glass of water with each dose take 2 caplets every 6 hours; not more than 8 caplets in 24 hours adults and children 12 years and over: ask a doctor children under 12 years:
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID) **
Caffeine 65 mg
**nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual & menstrual cramps
Warnings
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. Reye’s syndrome:
Acetaminophen may cause severe skin reactions. Symptoms may include:
Allergy alert :
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include: Allergy alert:
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding 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. Caffeine warning:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- are age 60 or older
- 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]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or other pain reliever/fever reducer
- with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms occur
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 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.
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 children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- drink a full glass of water with each dose
- take 2 caplets every 6 hours; not more than 8 caplets in 24 hours adults and children 12 years and over:
- ask a doctor children under 12 years:
Other information
- store at 20°-25°C (68°-77°F)
- close cap tightly after use
Inactive ingredients
corn starch, hypromellose, microcrystalline cellulose, povidone, propylene glycol, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.
Questions?
call toll-free 1-800-935-6737
Package Labeling:
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54257-858-02 | Extraprin | 100 in 1 BOTTLE | TABLET | 100 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Extraprin
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- PROPYLENE GLYCOL
- SILICON DIOXIDE
- STEARIC ACID
- TITANIUM DIOXIDE
- TRIACETIN
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54257-858 | 54257-858-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | 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 |
|---|---|---|---|---|---|---|
| Extraprin | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Magno-Humphries, Inc. | 9d22cdc8-29c5-4273-e053-2a95a90ad0bf | 2023-10-27 | Warnings | 54257-858-02 54257-858 54257085802 08bf8c82-76d4-440e-e063-6294a90af3d3 9d22cdc8-29c5-4273-e053-2a95a90ad0bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.