Indications and uses
Temporarily relieves minor aches and pains due to: - headache - muscular aches - a cold - arthritis - toothache - premenstrual and menstrual cramps
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
- Manufacturer
- Farmacias De Similares TX LLC | Contract Pharmacal Corp
- Effective date
- 2026-01-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:48:14
Label at a glance#
ProductDr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections
Dosage and administration
- 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
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
Purposes
Acetaminophen 250 mg...............................Pain reliever
Aspirin 250 mg (NSAID*).............................Pain reliever
Caffeine 65 mg............................................Pain reliever aid
*nonsteroidal anti-inflammatory drug
Uses
Temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- a cold
- arthritis
- toothache
- premenstrual and menstrual cramps
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: Aspirin may cause a severe allergic reaction, which may include: - hives - facial swelling - shock - asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skinreactions. Symptoms may include: - skin reddening - blisters - rash
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: - with other drugs containing acetaminophen - more than 8 caplets in 24 hours, which is the maximum daily amount - 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:
- are age 60 or older
- take more or for a longer time than directed
- 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
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
- 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 doctor before use if
-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 have asthma
- you are taking a diuretic
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 - have bloody or black stools - vomit blood - have stomach pain that does not get better - ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
- any new symptoms appear.
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
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.
Directions
- 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
Other information
- store in a dry place at 15° -30°C (59° - 86°F)
- use by expiration date on package
Inactive ingredients
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
Questions or comments?
855-280-1079
SPL UNCLASSIFIED SECTION
t This product is not manufactured or distributed by Haleon, owner of the registered trademark Excedrin®.
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 85786-105-90
Compare to Excedrin® Extra Strength Headache Relief Active ingredients t
Extra Strength Acetaminophen 250 mg, Aspirin 250 mg (NSAID)* and Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
100 Caplets
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 |
|---|---|---|---|---|---|---|
| 85786-105-90 | Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
- Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg
- ACETAMINOPHEN
- MEDIUM-CHAIN TRIGLYCERIDES
- MICROCRYSTALLINE CELLULOSE
- STARCH, CORN
- SILICON DIOXIDE
- STEARIC ACID
- MALTODEXTRIN
- POVIDONE K30
- POLYDEXTROSE
- TITANIUM DIOXIDE
- TALC
- HYPROMELLOSES
- ASPIRIN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-105 | 85786-105-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| 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 |
|---|---|---|---|---|---|---|
| Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg | ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG | Farmacias De Similares TX LLC | 48ea0a2c-511b-4805-e063-6394a90a1225 | 2026-01-21 | Warnings | 85786-105-90 85786-105 85786010590 48ea0a2c-511c-4805-e063-6394a90a1225 48ea0a2c-511b-4805-e063-6394a90a1225 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.