ASPIRIN 81MG ADULT LOW DOSE

Set ID
199f0043-17f6-4620-9658-b4b07fb50be7
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:42

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet) Aspirin 81 mg (NSAID)nonsterodial anti-inflammatory drug

Purpose Pain reliever

Uses

Uses

Warnings

Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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

Do not Use if you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if stomach bleeding warning applies to you you ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic, you have asthama

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking a prescription drug for:Gout, Diabetes, Arthritis

Directions And Dosage

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

Other Label Information

Other information

Store at room temparature. Avoid excessive heat above 40°C (104 °F)

Inactive ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10, Lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions or Comments

1-888-333-9792

Principal Display

Products

NDC Codes

Ingredients

NameUNIIKind
METHACRYLIC ACID1CS02G8656IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ASPIRINR16CO5Y76EACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet) Aspirin 81 mg (NSAID)nonsterodial anti-inflammatory drug

OTC - ACTIVE INGREDIENT SECTION

Purpose Pain reliever

OTC - PURPOSE SECTION

Uses

INDICATIONS & USAGE SECTION

Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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

WARNINGS SECTION

Do not Use if you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients

OTC - DO NOT USE SECTION

Ask a doctor before use if stomach bleeding warning applies to you you ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic, you have asthama

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking a prescription drug for:Gout, Diabetes, Arthritis

OTC - ASK DOCTOR/PHARMACIST SECTION

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, vomt blood, have bloody or black stools, have stomach pain that does not get better, pain get worse or lasts more than 10 days, fever gets worse or lasts more than 3 daysredness or swelling is present, new symptons occurringing in the ears or a loss of hearing occurs.

OTC - STOP USE SECTION

If pregnant or breast-feeding ask ahealth professional before use. it is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it my cause problems in the unborn child or complications during delivery.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children In case of overdose, get medical help or contact poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

STORAGE AND HANDLING SECTION

Store at room temparature. Avoid excessive heat above 40°C (104 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10, Lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions or Comments

OTC - QUESTIONS SECTION

1-888-333-9792

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc292de224-4f72-28dd-e063-6394a90a08b6.xml2024-12-15
otc0c7c4492-ef51-0614-e063-6294a90a78ba.xml2023-12-15
otcCarton.jpg2023-12-15