Acetaminophen, Aspirin, and Caffeine

Manufacturer
Bi-Mart | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:21

Label at a glance#

ProductAcetaminophen, Aspirin, and Caffeine
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

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; not more than 8 caplets in 24 hours •  children under 12 years: ask a doctor

Storage and handling

store at 20°-25°C(68°-77°F) close cap tightly after use DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Label contents#

Full prescribing information#

Active ingredients (in each geltab)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)**

Caffeine 65 mg

**nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

• headache

• a cold

• arthritis

• muscular aches

• toothache

• premenstrual & menstrual cramps

Warnings

WARNINGS SECTION

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 skin reactions. Symptoms may include: • skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert:Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• 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

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 • 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

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 occasional 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 are taking a diuretic • you have asthma

Ask a doctor or pharmacist before use if you are
• taking aa 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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

•  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 years:ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C(68°-77°F)
  • close cap tightly after use
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL-100 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-531-01

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

labellabel

PRINCIPAL DISPLAY PANEL-250 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-531-25

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-531-01Acetaminophen, Aspirin, and Caffeine100 in 1 BOTTLETABLET1002
37835-531-25Acetaminophen, Aspirin, and Caffeine250 in 1 BOTTLETABLET2502

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-53137835-531-01, 37835-531-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Aspirin, and CaffeineACETAMINOPHEN, ASPIRIN, AND CAFFEINEBi-Mart40cd1a7a-e941-4503-8fe4-e939bd0d9d722025-07-02WarningsExact identifier
ndc (package): 37835-531-01
ndc (package): 37835-531-25
ndc (product): 37835-531
ndc11 (package): 37835053101
ndc11 (package): 37835053125
spl id: 38f72774-7c51-b84f-e063-6394a90a8e64
spl set id: 40cd1a7a-e941-4503-8fe4-e939bd0d9d72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.