49483-390 ASA 81 MG

Set ID
7146c505-2469-4bc2-9e1e-ceb60951c8ae
Manufacturer
Time-Cap Labs, Inc
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:43

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Uses • temporarily relieves minor aches and pains • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Warnings

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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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)

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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 children under 12 years: consult a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here

Products

NDC Codes

Ingredients

NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
POLYSORBATE 806OZP39ZG8HIACT
DIMETHICONE92RU3N3Y1OIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ASPIRINR16CO5Y76EACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Uses • temporarily relieves minor aches and pains • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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 children under 12 years: consult a doctor

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 high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma • you have not been drinking fluids • you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • under a doctor’s care for any serious condition • taking any other drug

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 • under a doctor’s care for any serious condition • taking any other drug

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 cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/7146c505-2469-4bc2-9e1e-ceb60951c8ae/7d3f7c1d-79ea-acce-e053-2a91aa0acd38.xml
XML SHA-256
45abd93b55c2053707c2c7409e0355090e93b5c21b706261fe5530bd04c48bb2
XML bytes
27551

Legacy File Index

FolderFileDate
otc390BULK.jpg2018-12-18
otc7d3f7c1d-79ea-acce-e053-2a91aa0acd38.xml2018-12-18