Aspirin 325 mg tablets

Set ID
fe12519c-3e5f-4592-bd34-2d6b81b981f4
Manufacturer
TIME CAP LABS INC
Effective date
2023-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:42

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose Pain reliever

Uses

INDICATIONS AND USAGE

Uses for the temporary relief of minor aches and pains due to headache colds menstrual pain muscle pain toothache minor pain of arthritis or as directed by your doctor

Warnings

WARNINGS 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. 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 shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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 casue problems in the unborn child or complications during delivery.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC Codes

Ingredients

NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT

Complete SPL Sections

DRUG FACTS

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Pain reliever

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses for the temporary relief of minor aches and pains due to headache colds menstrual pain muscle pain toothache minor pain of arthritis or as directed by your doctor

WARNINGS SECTION

WARNINGS 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. 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 shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painfull area any new symptoms appear ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 casue problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
31946

Legacy File Index

FolderFileDate
otc0acac93d-0f05-0658-e063-6294a90a83c3.xml2023-11-23
otctimely-aspirin325-300s.jpg2023-11-23
otc11R-TCL-Aspirin 325 mg-bottle label-1000s.jpg2021-11-23
otc11R-TCL-Aspirin 325 mg-bottle label-100s.jpg2021-11-23
otc11R-TCL-Aspirin 325 mg-bulk label.jpg2021-11-23
otcd0cd252a-5b78-7de9-e053-2995a90a5843.xml2021-11-23
otc011RLABEL1M.jpg2014-04-25
otc44323eb2-3218-42a3-92a3-35569c11d8f8.xml2014-04-25