ASPIRIN 325 MG TABLETS

Set ID
9efd2b0e-64f0-4ca2-bce3-075f08312096
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:42:05

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Aspirin (NSAID)* 325 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

INDICATIONS & USAGE SECTION

temporary relieves minor aches and pains due to: headache minor arthritis pain toothache menstrual pain colds or as recommended by a doctor

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 shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause 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 aspirin or 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 phamracist before use if you are

taking a prescription drug for diabetis, gout or arthritis

Directions And Dosage

Directions

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose. do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years of age: ask a doctor

Other Label Information

Other information

store below 25 0 C (77 0 F) Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

Questions or comments?

1(888)333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS TM Compare to the active ingredient in ECOTRIN ® TABLETS* REGULAR STRENGTH ASPIRIN PAIN RELIEVER (NSAID) SAFETY COATED PROTECT AGAINST STOMACH UPSET 500 TABLETS

Products

NDC Codes

Ingredients

NameUNIIKind
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 806OZP39ZG8HIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ASPIRINR16CO5Y76EACTIB

Complete SPL Sections

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin (NSAID)* 325 mg *nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

temporary relieves minor aches and pains due to: headache minor arthritis pain toothache menstrual pain colds or as recommended by a doctor

WARNINGS SECTION

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 shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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 phamracist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for diabetis, gout or arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 any new symptom appear ringing in the ears or a loss of hearing occurs These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose. do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store below 25 0 C (77 0 F) Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1(888)333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS TM Compare to the active ingredient in ECOTRIN ® TABLETS* REGULAR STRENGTH ASPIRIN PAIN RELIEVER (NSAID) SAFETY COATED PROTECT AGAINST STOMACH UPSET 500 TABLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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otcaspirin 325 mg.jpg2018-04-19