First Aid Direct Aspirin

Manufacturer
Cintas Corporation
Effective date
2021-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:46:13

Label at a glance#

ProductFirst Aid Direct Aspirin
Active ingredientASPIRIN
Label structure4 sections

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Active ingredient (in each tablet)
• Aspirin 325mg (Nonsteroidal Anti-Inflammatory Drug (NSAID)…….Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves fever and minor aches and pains associated with:
• Headache
• Colds
• Muscular aches
• Menstrual discomfort
• Toothache
• Minor arthritis pain

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: 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
Do not use
• If you are allergic to aspirin
• With any other pain reliever/fever reducer
• For pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
Ask a doctor before use if:
• The stomach bleeding warning applies to you
• You have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, or kidney disease
• You are taking a diuretic
• You have a history of stomach problems such as heartburn
Ask a doctor or pharmacist before use if are taking a prescription drug for:
• Anticoagulation (thinning of blood)
• Diabetes
• Gout
• Arthritis
When using this product do not exceed recommended dose
Stop use and ask a doctor if:
• 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
• Pain or fever persists or gets worse
• New symptoms occur
• Redness or swelling is present
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 pregnancy.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 12 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

• Do not use if packet is torn, cut, or opened
• Store at room temperature
• Avoid excessive heat and humidity
Questions? 1-800-327-2704 M – F 8AM – 5PM (CDT)
2 tablets per packet

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aspirin............... 325mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Corn Starch, microcrystalline cellulose, povidone, silicon dioxide, and stearic acid

KEEP OUT OF REACH OF CHILDREN

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 right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Count Box50 Count Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box of 100Box of 100Box of 100Box of 100

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-11342961-113-01, 42961-113-02, 42961-113-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
57eae88b-ceae-44d1-a5df-3e96ee2266433dcf9e68-10d7-4a67-a250-9c786d25bc062022-12-30WarningsExact identifier
spl set id: 3dcf9e68-10d7-4a67-a250-9c786d25bc06

Reported adverse events (FAERS/openFDA)#

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