Acetaminophen, Aspirin, Caffeine

Product NDC
0536-1326
11-digit product format
005361326
Labeler code
0536
Product ID
0536-1326_17f8ba0e-5368-583e-e063-6394a90af22a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262024-05-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 skin reactions. 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 a...

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen, Aspirin, Caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN250 mg/1
CAFFEINE250 mg/1
ACETAMINOPHEN65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 3G6A5W338E, 362O9ITL9D
Rxcui308297

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1326-01Acetaminophen, Aspirin, Caffeine100 in 1 BOTTLETABLET, FILM COATED1003
0536-1326-01Acetaminophen, Aspirin, Caffeine1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1326-01EA - Each0536-13260d809eff-8115-4130-a21f-1cebfd60ea3812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1326ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240509_c3df1652-96a8-6043-e053-2995a90a2d26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNc3df1652-96a8-6043-e053-2995a90a2d263
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDc3df1652-96a8-6043-e053-2995a90a2d263
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYc3df1652-96a8-6043-e053-2995a90a2d263
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN437e4fd9-c7d9-77d6-e063-6294a90a22b71
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNaf8b30a0-7a56-4557-8404-cc8059fcd6bc1
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD437e4fd9-c7d9-77d6-e063-6294a90a22b71
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDaf8b30a0-7a56-4557-8404-cc8059fcd6bc1
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY437e4fd9-c7d9-77d6-e063-6294a90a22b71
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYaf8b30a0-7a56-4557-8404-cc8059fcd6bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1326-01005361326011 BOTTLE in 1 CARTON (0536-1326-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-06-030000-00-00NoNoCurrent