ASPIRIN — v4

ASPIRIN

7 Views

Version

v4

Effective date

October 1, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
401f8cd0-5b2e-d6b0-e063-6394a90ad8e8
Set ID
14cb1d2d-95b8-447e-8d79-e6ec82c0e431
Application numbers
M013
Product NDCs
68998-018
Package NDCs
68998-018-11, 68998-018-14
Original packager NDCs

Names & Manufacturers

Brand names
ASPIRIN
Generic names
ASPIRIN
Manufacturer names
Marc Glassman, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ASPIRIN
Routes
ORAL
Pharmacologic class (PE)
Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE]
Pharmacologic class (EPC)
Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
Pharmacologic class (CS)
Anti-Inflammatory Agents, Non-Steroidal [CS]
Mechanism of action
Cyclooxygenase Inhibitors [MoA]

Other identifiers

NUI
M0001335, N0000000160, N0000008832, N0000008836, N0000175578, N0000175722
RxCUI
212033
UNII
R16CO5Y76E
UPC
0099581910426

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Aspirin 325 mg (NSAID nonsteroidal anti-inflammatory drug )
Ask Doctor (1)

Sequence 1

Ask a doctor before use if 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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes gout arthritis
Do Not Use (1)

Sequence 1

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
Dosage And Administration (1)

Sequence 1

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years: consult a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, starch, titanium dioxide
Indications And Usage (1)

Sequence 1

Uses temporarily relieves: headache muscle pain toothache menstrual pain pain of colds minor pain of arthritis temporarily reduces fever
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL Marc’s® NDC 68998-018-11 †Compare to the active ingredient in Bayer® Aspirin Tablets Regular Strength Aspirin Pain Reliever/Fever Reducer (NSAID) Acutal Size 100 COATED TABLETS 325 MG EACH image description
Pregnancy Or Breast Feeding (1)

Sequence 1

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.
Purpose (1)

Sequence 1

Purpose Pain reliever/fever reducer
Spl Product Data Elements (1)

Sequence 1

ASPIRIN ASPIRIN CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN TITANIUM DIOXIDE ASPIRIN ASPIRIN TCL;011
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Stop Use (1)

Sequence 1

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 pain gets worse or lasts for more than 10 days redness or swelling is present fever gets worse or lasts for more than 3 days new symptoms occur ringing in the ears or loss of hearing occurs These could be signs of a serious condition.
Storage And Handling (1)

Sequence 1

Other information store between 20°-25°C (68°-77°F) in a dry place retain carton for complete product information
Warnings (1)

Sequence 1

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) 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 Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if 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 arthritis 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 pain gets worse or lasts for more than 10 days redness or swelling is present fever gets worse or lasts for more than 3 days new symptoms occur ringing in the ears or loss of hearing occurs 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 right away (1-800-222-1222).

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['ASPIRIN'],
 'generic_name': ['ASPIRIN'],
 'is_original_packager': [True],
 'manufacturer_name': ['Marc Glassman, Inc.'],
 'nui': ['N0000000160',
         'N0000008836',
         'M0001335',
         'N0000175722',
         'N0000175578',
         'N0000008832'],
 'package_ndc': ['68998-018-11', '68998-018-14'],
 'pharm_class_cs': ['Anti-Inflammatory Agents, Non-Steroidal [CS]'],
 'pharm_class_epc': ['Nonsteroidal Anti-inflammatory Drug [EPC]',
                     'Platelet Aggregation Inhibitor [EPC]'],
 'pharm_class_moa': ['Cyclooxygenase Inhibitors [MoA]'],
 'pharm_class_pe': ['Decreased Prostaglandin Production [PE]',
                    'Decreased Platelet Aggregation [PE]'],
 'product_ndc': ['68998-018'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['212033'],
 'spl_id': ['401f8cd0-5b2e-d6b0-e063-6394a90ad8e8'],
 'spl_set_id': ['14cb1d2d-95b8-447e-8d79-e6ec82c0e431'],
 'substance_name': ['ASPIRIN'],
 'unii': ['R16CO5Y76E'],
 'upc': ['0099581910426']}