CHEWABLE LOW DOSE

Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:47:07

Label at a glance#

ProductCHEWABLE LOW DOSE
Active ingredientASPIRIN
Label structure13 sections

Indications and uses

■ for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief. ■ ask your doctor about other uses for Aspirin 81 mg

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

■ for the temporary relief of minor aches and pains
or as recommended by your doctor. Because of
its delayed action, this product will not provide
fast relief of headaches, fever or other symptoms
needing immediate relief.
■ ask your doctor about other uses for Aspirin 81 mg

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.

WARNINGS SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

■ if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for
■ gout ■ diabetes ■ arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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 more than 10 days
■ redness or swelling is present
■ new symptoms occur
■ ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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. 1(800)222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: sodium 0.22 mg
■ store at room temperature
■ save carton for full directions and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT (Butylated Hydroxytoluene), dextrates, FD&C
Yellow #6 Aluminum Lake, microcrystalline
cellulose, modified corn starch, orange flavor,
pregelatinized starch, sucralose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT OF
BAYER® CHEWABLE LOW DOSE ASPIRIN†

FAMILY wellness

NDC 68210-2200-3

CHEWABLE LOW DOSE

Aspirin 81 mg

Pain Reliever (NSAID)
Aspirin Regimen

36 ORANGE FLAVORED TABLETS

ACTUAL SIZE

image descriptionimage description

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-220068210-2200-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
0c027a3d-8029-53c7-e063-6294a90aa397a25d8e5c-8250-4fe6-8261-2be47afdfe752023-12-08WarningsExact identifier
spl set id: a25d8e5c-8250-4fe6-8261-2be47afdfe75

Reported adverse events (FAERS/openFDA)#

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