First Aid Direct Chewable Aspirin — v6

First Aid Direct Chewable Aspirin

6 Views

Version

v6

Effective date

September 25, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
2e7ee264-5dfc-41c1-82e4-fbfd28523b5d
Set ID
ff6960f6-9f55-4f32-9ab5-9187724531e9
Application numbers
M013
Product NDCs
42961-104
Package NDCs
42961-104-02
Original packager NDCs
—

Names & Manufacturers

Brand names
First Aid Direct Chewable Aspirin
Generic names
ASPIRIN
Manufacturer names
Cintas Corp
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
318272
UNII
R16CO5Y76E
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Aspirin 81 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 gout diabetes arthritis
Do Not Use (1)

Sequence 1

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Dosage And Administration (1)

Sequence 1

Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium
Indications And Usage (1)

Sequence 1

Uses for the temporary relief of minor aches and pains or as recommended by your doctor ask your doctor about other uses for 81mg chewable aspirin
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Safety Information (1)

Sequence 1

Other information store at room temperature Keep out of reach of children
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel LOW DOSE ASPIRIN 25 Chewable Tablets 1 Tablet per packet Pain Reliever Temporary relief of minor aches and pains or as recommended by your doctor Compare active ingredient to Bayer® Chewable Aspirin Manufactured for: fad first aid direct Mason, OH 45040 LOW DOSE ASPIRIN PAIN RELIEVER (NSAID) Each chewable tablet contains: Aspirin 81mg (NSAID*) LDA_PDP1 LDA_PDP2
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 specifically 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
Questions (1)

Sequence 1

Questions? 1-800-327-2704 M-F 8am - 5pm (CDT)
Spl Product Data Elements (1)

Sequence 1

First Aid Direct Chewable Aspirin Aspirin ASPIRIN ASPIRIN STARCH, CORN DEXTRATES FD&C YELLOW NO. 6 SACCHARIN SODIUM AZ013
Stop Use (1)

Sequence 1

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma
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 Allert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['First Aid Direct Chewable Aspirin'],
 'generic_name': ['ASPIRIN'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corp'],
 'nui': ['N0000000160',
         'N0000008836',
         'M0001335',
         'N0000175722',
         'N0000175578',
         'N0000008832'],
 'package_ndc': ['42961-104-02'],
 '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': ['42961-104'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['318272'],
 'spl_id': ['2e7ee264-5dfc-41c1-82e4-fbfd28523b5d'],
 'spl_set_id': ['ff6960f6-9f55-4f32-9ab5-9187724531e9'],
 'substance_name': ['ASPIRIN'],
 'unii': ['R16CO5Y76E']}